5,292 Validation Engineer jobs in the United States
Senior Quality Assurance and Validation Engineer
Posted 21 days ago
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Who is Meissner?
The goal at Meissner is to be more than simply good; it is to be extraordinary. Extraordinary performance comes from extraordinary people.
Meissner as a group is passionate about helping our clients manufacture lifesaving and life enhancing drugs, therapies, and vaccines. We develop, manufacture, supply and service advanced microfiltration products and single-use systems worldwide.
We know that when you are passionate about what you do, it's more than just a job.
Meissner is focused on the development of the whole individual, and we have programs and tools in place to help us stay at our best mentally and physically. In alignment with our commitment to support the growth and development of the whole individual, Meissner has inaugurated a Learning and Development department to solely focus on cultivating our team. When you grow, we grow.
How you will make an impact:
We are seeking a proactive and detail-driven Quality Assurance and Validation Engineer to play a critical role in maintaining quality systems compliance, ensuring product and process compliance with internal quality standards and external regulatory requirements as well as the ongoing support of irradiation operations. This role combines core quality engineering functions with specialized responsibilities in equipment/process validation, system qualification, and internal and supplier auditing. The ideal candidate will be well versed in quality management systems, risk management, and regulatory frameworks such cGMP.
- Ensure quality system compliance across product receipt, handling, processing, and distribution processes.
- Support product lifecycle activities through quality engineering best practices.
- Develop and maintain Validation Master Plans (VMP).
- Author, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Process Performance Qualification (PPQ) protocols for equipment, systems, products and processes.
- Lead customer audits and regulatory inspections related to irradiation operations.
- Follow up on audit findings to ensure timely and effective corrective actions.
The skills and experience you'll need:
- Bachelor's degree in a technical or scientific field (e.g., Engineering, Life Sciences, Quality Management) required.
- 7+ years of experience in Quality Assurance within a regulated industry (e.g., medical devices, pharma, biotech, manufacturing).
- Direct experience in process development and/or validation for at least one of the common irradiation method (gamma, xray or ebeam).
- Awareness of applicable sterilization standards, specifically ISO 11137.
- Familiarity with sterilization processes and applicable standards, including cycle design, validation, dosimetric aspects, and process control.
- Experience with validation/qualification protocols and audit programs.
What we can offer you:
- Full Medical, Dental and Vision coverage with HSA Employer Contributions for eligible plans
- Additional Perks- HQ Onsite Full Gym, Ultramodern Coffee Bars, Free EV Charging Stations, Employee Discounts
- 401k, Profit Sharing, 401k Advisory Services
- Employee Assistance Program
- Paid Time Off, Paid Holidays, Anniversary Holiday
Ready to make an impact? Let's talk.
Meissner is proud to be an Equal Opportunity Employer.
US BASE PAY SCALE $94,400 - $133,300
The base pay scale for this role is what Meissner reasonably expects to pay for the position although actual pay may vary from this scale depending on an applicant's experience.
Validation Engineer
Posted today
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
ABOUT ABBOTT
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
This position works out of our Columbus, Ohio plant location in the Abbott Nutrition Division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® - to help them get the nutrients they need to live their healthiest lives.
The Columbus Plant is Abbott's first manufacturing facility in the world, making us a leader in science-backed nutrition products. Working here, you'll be part of a family that works together to produce quality products that make a difference and help keep consumers nourished at every stage of their lives.
WORKING AT ABBOTT
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
- Production areas that are clean, well-lit and temperature-controlled
- Training and career development , with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
- Vacation - 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
- Retiree Healthcare program
- Robust 401(k) retirement savings with a generous company match
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A stable company with a record of strong financial performance and history of being actively involved in local communities
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
THE OPPORTUNITY
Coordinates schedules and implementing activities for the Distribution function, that include overseeing personnel, directing operations and following-up on transactions, to ensure department standards and the Regulations are observed. Manages sterilization, returned goods, receipt, storage and transaction of finished goods in accordance with validated procedures. Ensures that customer orders are processed quickly and accurately to meet Division standards.
WHAT YOU'LL DO
- As a Validation Engineer, you'll have the chance to create and implement the Abbott Division validation program. Creates and maintains validation documentation for new and existing systems and processes subject to design control. Ensures that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.
- Ensure that change control and validation activities are executed in a timely manner while following all Abbott Nutrition Policies and Standards.
- Lead and support Design Qualification processes including: Installation / Operational Qualification (IOQ), Performance Qualification (PQ) , System Impact Assessments (SIA), Project Validation Plan (PVP), Failure Mode Effects Analysis (FMEA), and User Requirement Specifications (URS) for new installations or major changes.
- Strong understanding and implementation of the CAPA management system
- Develop, execute and review FDA validation protocols and related documentation in accordance with procedures and policies
- Support resolution of validation events and escalate concerns in a timely manner
- Comply to all FDA policies and standards
- Use M-Files to house all validation and control documentation
- Any other requests as assigned by supervisor
REQUIRED QUALIFICATIONS
- A Bachelor's Degree , preferred degree in engineering or technical field.
- 1-3+ years' work experience in Quality, Validation, Engineering manufacturing, food industry, or industries with similar levels of regulatory oversight such as laboratory diagnostics, medical devices, pharmaceutical, etc.
- Understanding of Design Control, Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA's Computer Software Assurance initiatives are preferred.
- Experienced in protocol writing and execution, closure of validation activities such as Installation / Operational Qualification (IOQ), Performance Qualification (PQ)
- Ability to execute findings and develop project scope for execution.
- Drive to lead projects and understand project timelines.
PREFERRED QUALIFICATIONS
- Experience in an FDA regulated environment.
- Experience in Chemical, Mechanical, Quality, or Validation Engineering
Apply Now
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Pre-Employment Inquiries and Citizenship | U.S. Equal Employment Opportunity Commission ()
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
*Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer and a Military/Veteran friendly Employer, committed to employee diversity.
Connect with us at , on Facebook at , and on Twitter @AbbottNews.
The base pay for this position is $60,000.00 - $120,000.00. In specific locations, the pay range may vary from the range posted.
Validation Engineer
Posted today
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Job Description
- Currently our client is building out a validation team and they are looking for a validation specialist to come in and help with all support work and all the projects they have for the year.
- The client is looking for an individual who has experience in validation and who has good execution.
- This individual needs to have very strong on the floor execution experience in order to be a good fit.
- The client has more equipment and work coming in than expected. They are needing a Validation Specialists with Equipment/Sterilization experience.
- Experience with Isolators (vhp) and Autoclaves are a MUST. MUST have experience with thermocouples and data loggers, strong technical writing experience.
- There will be cycle development and pre-cycle development work to be performed.
- If candidates have variable load experience, that would be a huge plus.
- Experience with Autoclave, thermocouples, and data loggers.
- Elba's Autoclaves VHP Cleaning Validation Technical Writing Good documentation skills good communication Technically sound energetic person Willing to collaborate and learn good team chemistry.
- Humble Flexible person Character is important - good personality Temperature mapping.
- Experience with Bioreactors Plus: Drug Product Experience.
Validation Engineer
Posted today
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Job Description
**Additional Manager notes**
This candidate will be assisting with supplier quality work, visiting suppliers, having supplier calls, and going over general quality information with suppliers. They will also assist the suppliers by reviewing their parts submissions and making sure specifications are met. This candidate should be familiar with AIAG - Automotive Industry Action Group & APQP - Advanced Product Quality Planning. Someone with a strong automotive background will be a bonus. This candidate should at least have 5 year's experience doing the same.
The shift for this role is M-F 8AM-5PM. This is a hybrid role working 2 days in the office and 3 days remote. The candidate will need to local or near the Columbus area. When the manager is ready, he will be requesting 1 hour zoom interviews.
"Summary: Research and test the design, functionality and maintenance of products, equipment, systems and processes and develop quality standards. Ability to read and interpret blueprints, and evaluate product integrity and standards. Typically has a Bachelors degree in an engineering discipline. The technical skills include the ability to make sketches and engineering drawings and experience using computer applications related to the engineering field.Education/Experienceo Bachelor degree in engineering requiredo 8-10 years experience required Responsibility levelo Exercises independent judgment with minimal direction from supervisorSkillso Creativity, verbal and written communication skills, analytical and problem solving ability (Required)o Team player and detail oriented (Required)o Strong leadership and mentoring skills necessary to provide support and constructive performance feedback (Required)o Strong ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports (Typically required)o Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD) (Typically required)Major Job Duties and Responsibilities:o Review and approve sampling procedures and designs, forms and instructions for recording, evaluating, and reporting quality and reliability datao Review and supervise programs to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilitieso May conduct training sessions on quality control activitieso Considered a specialist in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, research and development, and administrative application o Directs workers engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability o Plans and directs activities concerned with development, application, and maintenance of quality standards for industrial processes, materials, and products o Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as chemical, electrical, or mechanical o May manage quality control program "
Top Skills you are looking for:
1.Quality background in Auto Industry
2.Working with supplier
3.GD&T - Geometric Dimensioning and Tolerancing knowledge
4.Quality Statistical knowledge
Validation Engineer
Posted today
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- Packaging, Cleanroom, Equipment validation, Process Validation, IQ, OQ, PQ, Product transfer and Manufacturing transfer.
- 4-6 years of experience is required.
- Validation Engineer Manufacturing Engineer with Packaging, Cleanroom, Equipment machine validation experience good communication skill- good experience in validations (IQ/OQ/PQ).
- 5+ years of Working Experience machine shop environment. Good communication skills, Machining background, has worked in a Packaging, Cleanroom, Equipment machine shop environment (within med device or aerospace preferred).
- Product / Manufacturing Transfer activities, Good experience validations (IQ/OQ/PQ).
- Understanding of different types of metal/plastic cutting manufacturing processes.
- Basic understanding of Packaging, clean room, milling and or lathe machines.
- Understanding of basic Quality systems.
Validation Engineer
Posted today
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Summary: Under general supervision, reviews specifications and determines the critical aspects
of facilities, utilities, computer systems and manufacturing equipment with regard to product and
process quality, writes qualification protocols for operating systems and records related test
results; prepares final reports that identify the results of protocol testing and the conditions of
release.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide
representative summary of the major duties and responsibilities. Incumbent(s) may not be
required to perform all duties listed, and may be required to perform additional, position-specific
tasks.
• Carries out responsibilities in accordance with the organization's policies, procedures,
and state, federal and local laws.
• Reviews electrical, mechanical, and software/computer specifications in manufacturer
and blue print form, and identifies critical parameters.
• Writes protocols that challenge the critical parameters related to installation, operation,
and performance of the related facility, utilities, computer systems, or equipment.
• ssures that protocols are approved through proper channels; writes and revises
validation protocols.
• Executes validation and qualification protocols per related SOPs and assures that
acceptance criterion related to validation and qualification protocols are met.
• ssures that all test data is gathered and recorded in accordance with cGMP
requirements.
• nalyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation
reports as required upon failures to meet protocol acceptance criteria.
• Writes final reports and assures that they are approved through proper channels.
• Develops and communicates project timelines and status.
• Complies with all GMP and safety requirements, SOP's and Company policies and
procedures.
Performs equipment and system qualification periodic reviews.
• Performs related duties as assigned.
Required Knowledge and Skills :
Knowledge of :
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),
and other regulatory requirements.
• Pharmaceutical principles, practices and applications.
• English usage, spelling, grammar and punctuation.
• Principles of mathematical and statistical computations.
• Personal computer operations and Microsoft applications (Word, Access, and Excel).
Skill in:
• Interpreting software and ladder logic diagrams and flowcharts.
• Interpreting electrical, and mechanical blue prints and specifications including HVAC
systems and. construction plans.
• Solving practical problems and considering a variety of concrete variables in situations
where only limited standardization exists.
• Communicating clearly and concisely, both orally and in writing.
• Establishing and maintaining good relationships with those encountered in the course of
work.
• Operating a personal computer.
Physical Requirements and Working Conditions : Incumbents in this class are subject to
extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching
climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up
to 25 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and
dangerous tools and equipment. Work is performed in a manufacturing environment.
Minimum Qualifications: Bachelor's degree in Engineering or a related field from an accredited
college or university and zero (0) to one (1) year of engineering validation experience, preferably
in a pharmaceutical environment, or an equivalent combination of training and experience.
Validation Engineer
Posted today
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PACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis).
Job Description:
The Validation Engineer will manage various commissioning, qualification, and/or validation facets within our client’s Biotechnology and Pharmaceutical sites. This support service will work within the client’s validation, project management, quality, and/or automation department team(s).
Position Responsibilities/Essential Functions
-
- Develop and/or drive to completion the following Commissioning and Qualification (C&Q) deliverables: project validation plan, risk assessments and project strategies, requirements, functional design specifications, software/hardware design specifications, impact assessments, trace matrix, test cases/scripts, engineering studies, and summary reports.
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Thoroughly understand the commissioning and qualification process and influence cross-functional team members to ensure adherence to governing policy and procedure.
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Ensure change management is properly assessed throughout the course of the project and all documentation impacted is maintained. This includes changes due to evolving design and failures during test execution.
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Lead and participate in project review meetings such as design reviews, alignment sessions, test strategy, test execution reviews, project status, and qualification review meetings.
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Manage and report project scope and budget considerations as it relate to C&Q.
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Develop and maintain documentation within an electronic lifecycle management system capable of paperless execution.
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Support the execution of large capital projects that contribute to the expansion of pharmaceutical manufacturing. Projects may include the following types of equipment: active pharmaceutical ingredient manufacturing, filling operations, delivery device assembly, packaging, facilities and utilities, and automation.
Requirements
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- Bachelor’s degree in engineering or a technical discipline required
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2+ years of validation experience in the Pharmaceutical Industry
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Comfortable with a 24/7 manufacturing environment
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Works well with others within a team and takes accountability
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Can handle a high-pressure, high-stress work environment
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Result-driven and self-motivated
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Strong interpersonal and communication skills (verbal and presentation)
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Organized with strong computer literacy, such as MS Word, Project, Excel, etc.
Desired Hard Skill Sets (via Internships/Co-Ops):
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- Familiarity with Validation principles and executable deliverables (i.e. Requirements, Design, Testing, Reports, etc.)
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C&Q and/or CSV experience, ideally around Data Integrity and CFR Part 11 Electronic Records and Signatures
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Project Management experience with the ability to lead and drive projects to completion autonomously
Other Requirements
Location: Indianapolis
Travel: Up to 40% of the time to various suppliers, collaborators, and client sites outside of Indianapolis
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Validation Engineer
Posted today
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- Background from Quality Mazaak i200 and EMC Oven Machine Validation.
- cts as a resource to work groups and project teams, within the plant and outside the plant relative to quality and validation related activities.
- Need to have familiarity with manufacturing processes and products to evaluate the cause and effect of defects and identify trends in titanium machining process and product quality
- Provides technical input for projects using the application of FMEA's, risk mitigation, plant validations; DOE's' and other experiments and investigations as assigned.
- Working knowledge of Validations, IQ, OQ, PQ, SIMS and DOE's is desirable.
- Should possess good knowledge in Machining process and its defect remediation activities.
- Should have good understanding and experience in GD&T and complex drawing interpretation.
- Should have hands on experience in creating PFMEA and Process control plans.
- Should operate autonomously to review vendor documents, identify gaps and work with to close the gaps. Approve and assist in Launch of products.
- Co-ordinate with Vendor to complete the PPAP documentation.
- Should have sound experience in Non - conformance identification, RCA, CAPA and implementation from medical device manufacturing background.
- Proven track record of supporting and driving continuous improvement activities in a production environment.
- Bachelor's degree preferably Manufacturing, Industrial Engineering
- Bachelor's degree in science, engineering, or manufacturing discipline
- Experience in ISO-13485 certified and cGMP organizations preferred. Medical device manufacturing,
- Background from Quality Mazaak i200 and EMC Oven Machine Validation
Validation Engineer
Posted today
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- Designs and drafts validation sampling and testing plan/protocols.
- Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies.
- Resolve technical issues encountered during study execution.
- Track and expedite the review and sign-off of qualification documentation.
- Support execution of validation activities.
- Interact with individuals from different departments to plan, execute, and complete qualification activities.
- Drive the completion of validation efforts according to deadlines.
- Write / guide the writing of departmental procedures required for validation.
- Assist during internal and 3rd party audits wrt validation requirements.
- Initiate CAPAs, NCRs and Change Requests where required and assist with investigations.
- Assist with identifying maintenance and calibration requirements.
- Coordinate suppliers wrt Validation activities including obtaining quotes from suppliers.
- Validation administration such as updating the validation plan, maintaining databases, standard referencing of documentation.
- Review Validation plans, protocols and SOPs written by other validation team members.
- Manage workload arising from unscheduled events.
- Other duties as assigned by management.
- Validation Protocol Development and Execution: Expertise in creating and executing validation protocols (IQ, OQ, PQ, CSV, etc.).
- Regulatory Compliance Knowledge: Strong understanding of FDA, cGMP, GAMP, and related regulatory standards.
- Technical Problem-Solving: Ability to troubleshoot and resolve technical issues during validation.
- Cross-Functional Collaboration: Effective communication and coordination with internal teams and external suppliers.
- Documentation Management: Proficiency in managing validation documents, databases, and SOPs.
Validation Engineer
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- Provide metric reports to management during management reviews and reports.
- Implement quality programs and establish quality assurance measures at all key stages of manufacturing.
- Review of manufacturing, purchasing and test documentation to ensure requirements are fulfilled.
- Review drawings, specifications, procedures, test procedures, inspection and test analysis.
- Develop procedures for production testing and standardize inspection methods.
- Promote and train personnel to ensure awareness of regulatory and customer requirements throughout the company.
- ct as a technical team leader including training and developing less senior staff on the team.
- Support operations with quality issues/root cause analysis/corrective actions.
- Support the Quality Management System.
- Lead the development and execution of engineering studies, quality plans, validation packages, and Lead the development and execution of IQ, OQ and PQ protocols for product, processes and equipment within the facility.
- Write reports summarizing results and statistics for all equipment, product, or process validation projects.
- Trend and report on the Manufacturing NCRs - including process effectiveness and corrective and preventative actions and make recommendations for improvements.
- Develop and communicates expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.
- Participate as an active member in the new products development team.
- Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.
- Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
- Provide day-to-day support to engineering and manufacturing in implementing process improvement.
- ssist or lead process improvement projects (scrap reduction, defect reduction, etc.).
- Be able to assist, present, defend and communicate with internal and external auditors.
- Perform other duties as assigned.
- bachelor's degree in engineering.
- 5-8 years of related experience.
- Six Sigma Certification (Green Belt or Black Belt) is desirable.
- Experience in the medical device industry in development and deployment of Quality Systems, implementing process controls, and continuous improvement methodologies.
- Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.
- Knowledge and working application of validation principles and guidelines and industry practice.
- Knowledge and working application of PFMEA and Risk Analysis.
- Knowledge and working application of reading and understanding blueprints and technical drawings.
- Knowledge and working application of standard operating procedures.
- Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools.
- Understand and articulate how own role ties within function or discipline.
- Demonstration application of engineering principles on individual/small projects.
- Demonstrated strong analytical problem solving (CAPA), teaming and communications/interpersonal.
- Desired CQE, CSSBB, CQA or initiative to complete certifications.
- Prefer experience with TQM methods (e.g. "six sigma ").
- Internal Quality System auditing experience (ISO 13485 and FDA 21CFR820).
- Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
- bility to multi-task and methodically manage projects.
- bility to work independently and in team environments.