4,380 Senior Validation jobs in the United States

#2531 Validation Engineer - Pharmaceutical

Our client is a Fortune 500 Pharmaceutical Company with Global reach. They are currently looking for a strong Validation Engineer to join their tenured Validation team.

Key responsibilities for this role include:

• Provide direction, reviews and provides Quality approval for design qualification documents, validation protocols, summary reports, discrepancy reports and CPV reports.
• Provides the Quality Assurance review and approval of Engineering, Calibration, Facility Maintenance, Production Support (Maintenance), Technical Services and IT procedures and forms.
• Authors protocols and reports as required/assigned.
• Perform validation planning and tracking.
• Assist in the development and maintenance of the procedures defining the validation program at MTI.
• Participates in the evaluation of changes to validated systems to ensure the validate state is maintained. Provides direction, reviews and approves proposed changes and facilitates decision making regarding the extent of any re-validation requirements.
• Assist in the compilation of periodic reports required by the validation program.

The minimum qualifications for this role are:

• Bachelor of Science degree (or equivalent) and 7 + years in a pharmaceutical cGMP environment is required. A combination of experience and/or education will be taken into consideration.
• Must possess a working knowledge of Pharmaceutical validation and cGMP concepts.

Summary: Validation Engineer:

In this role, you will support site commissioning and qualification, which includes but is not limited to the following: equipment, utilities, cleaning, process, assay qualifications. Ensuring the timely development, execution, and coordination of all validation activities pertaining to facility, equipment, and process in compliance with Quality System requirements, site procedures and regulatory requirements. This role will develop validation and Quality System documentation (e.g., IQ/OQ/PQ/SOP/Change Controls/Deviations/CAPAs etc.). This role will organize all validation activities ensuring project completion per schedule requirements.

Job Description: Validation Engineer:

• Maintain the Company’s compliance with established company Standard Operating Procedures and specifications and Current Good Manufacturing Practices.
• Write, execute and coordinate commissioning, qualification and validation protocol testing.
• Compile relevant commissioning/qualification/validation study data and generate summary reports to document the results of the studies.
• Aid in troubleshooting/impact assessment for atypical conditions during studies/ validations.
• Assist in the maintenance and development of any existing validation programs to ensure continued compliance with regulatory requirements.
• Provide scientific rationale/strategy for studies of new or modified GMP equipment and processes.
• Ensure all aspects of validation and qualification adhere to site and corporate policies and procedures, including safety and training.
• Review all errors, protocol deviations, and comments with the respective user department Management and QA and resolve discrepancies.
• Ability to manage and plan multiple projects.
• Knowledge of cGMP’s, GDP’s and regulatory requirements as they related to qualification and validation activities (IQ/OQ/PQ).
• Possess a working knowledge of Microsoft Word, Windows, Excel, Power Point, and Statistical tools such as Minitab/JMP.
• Must possess excellent analytical skills, good problem-solving technique and data analysis skills using Excel.

Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws

PeopleSolutions is seeking a highly skilled Cleaning Validation Engineer to join a pharmaceutical manufacturing team. This role is pivotal in ensuring that cleaning processes within the facility meet stringent industry standards and regulatory compliance. The ideal candidate will collaborate closely with manufacturing, quality assurance, and regulatory functions to uphold product safety and efficacy through robust cleaning validation protocols.

Key Responsibilities:

• Develop and execute comprehensive cleaning validation protocols and plans.
• Conduct sampling and testing of production equipment and surfaces to verify cleanliness.
• Analyze laboratory and process data to ensure compliance with regulatory standards.
• Prepare validation reports and documentation suitable for regulatory submissions (FDA, EMA).
• Collaborate cross-functionally with manufacturing, QA, and regulatory teams to maintain cleaning process integrity.
• Ensure all activities adhere to cGMP and relevant industry guidelines.

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or related scientific discipline.
• Proven experience in pharmaceutical cleaning validation or related manufacturing environment.
• Strong knowledge of regulatory requirements including FDA, EMA, and ICH guidelines.
• Proficiency in analytical techniques used in cleaning verification (e.g., ATP, HPLC, TOC).
• Excellent documentation, communication, and organizational skills.
• Ability to work independently and as part of a multidisciplinary team.

Why Join Us:

• Opportunity to work in a dynamic environment manufacturing high-quality pharmaceutical and consumer health products.
• Collaborative culture focused on innovation and continuous improvement.
• Career growth opportunities and professional development support.
• Competitive compensation and benefits package.

Ready to make an impact? Apply now.

If you are interested in this or future opportunities in your area, please send a Word-Formatted resume to and we will contact you when opportunities arise that match your geography and experience. All inquiries are kept confidential, and your information will not be shared without your approval.

All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law.

Industry: Medical Devices

Title: Validation Engineer I

Job ID: ROCGJP

Location: Tucson, AZ

Duration: 12 months contract (High Chances of Extension)

Description:

We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity. This is an on-site position that focuses on process validation.

Responsibilities:

Develop, write, review, and execute process validation/process verification protocols and reports.

Conduct risk assessments and develop validation strategies for new and existing processes.

Analyze and interpret process validation data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.

Collaborate with Manufacturing, Quality, Design Transfer Operations, and other departments to resolve validation issues and implement corrective actions.

Participate in process optimization and continuous improvement initiatives to enhance quality and efficiency. Ensure compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements. Provide training and guidance to manufacturing and quality personnel on validation processes and procedures.

Maintain process validation documentation and ensure traceability and accessibility for audits and inspections.

Other duties as assigned by management.

Qualifications:

Bachelor's Degree in Engineering or Life Science.

Strong technical writing, analytical, and problem-solving skills.

Knowledge of cGMP and regulatory standards.

Strong understanding of process validation principles, techniques, and industry standards.

A large pharmaceutical client is seeking a team of Cleaning Equipment Validation Engineers to support their site build out in Raleigh-Durham. The ideal candidate will have hands on validation experience, documentation experience and experience working within regulated pharmaceutical environment. The first 3-4 months will be heavily focused on documentation and protocols. Once engineering runs begin in the fall, the role will move into the field supporting cleaning validation activities on the floor. Samples will be taken, protocols filled, and swaps taking place. Mid next year the site will move into 24/7 operations.

Responsibilities:

• Conduct PQs for parts washers and other cleaning equipment
• Define cleaning parameters & take samples
• Assist with CIP procedures and systems
• Communicate with vendors and teams onsite
• Develop and execute cleaning validation protocols and reports for new equipment and facilities.
• Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Conduct cleaning validation studies, including sampling, testing, and data analysis.
• Investigate and resolve deviations and discrepancies related to cleaning validation.
• Maintain accurate and detailed documentation of all cleaning validation activities.

Must Haves:

• 3+ years of experience with cleaning validation
• Bachelors Degree in Engineering or related field
• Experience with cGMP documentation and validation life cycle
• Experience writing cleaning validation reports, risk assessments, protocols and investigating and resolving deviations
• Experience with Kneat – high preference for this
• Experience with greenfield, brownfield or new facility build outs desirable

Validation Engineer – Medical Device Manufacturing

Indianapolis, IN | Onsite

Are you passionate about building medical solutions that truly matter? At our Indianapolis facility, we design and deliver life-saving medical products, from automated drug delivery systems to complex device assemblies. We’re growing our Validation team and are looking for a Validation Engineer who thrives in a regulated environment and is eager to make an impact in healthcare innovation.

This is not just another engineering job. It’s a chance to contribute to products that end up in the hands of patients worldwide — devices like auto-injectors that provide life-saving medication in critical moments. You’ll be part of a collaborative team that values quality, documentation excellence, and data-driven decision making.

What You’ll Do

• Develop and author Validation Plans (VPs) and protocols for all phases of the validation lifecycle.
• Execute test protocols, analyze data using statistical tools/software (Minitab, etc.), and communicate insights.
• Lead and schedule Validation Review Board (VRB) meetings, review and approve validation documentation, and allocate resources across projects.
• Support process and equipment qualifications (IQ, OQ, PQ) and test method validations.
• Partner with medical device customers to deliver validation processes that meet regulatory expectations.
• Maintain documentation in compliance with FDA 21 CFR 820, GMP, and ISO13485 requirements.
• Mentor other engineers on validation practices and contribute to continuous improvement initiatives.

What We’re Looking For

• 2–5 years of experience in validation, ideally in medical device manufacturing (highly regulated industries like aerospace may also be considered).
• Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering (or related).
• Hands-on knowledge of automated and manual assembly, molding, and packaging processes.
• Strong background in process characterization, GR&R studies, and statistical data analysis.
• Proven ability to balance multiple projects, prioritize effectively, and keep accurate records.
• Quality-driven mindset with the ability to lead in a compliance-focused environment.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Project, Visio).

What Success Looks Like

In the first 3 months: You’ll establish yourself in VRB meetings, support protocol/report generation, and contribute to validation for commissioning production systems.

By 6 months: You’ll lead VRB meetings, train peers in validation practices, and support lean manufacturing initiatives.

By 12 months: You’ll be championing the validation program, guiding team members, and driving continuous improvement across the validation lifecycle.

Schedule & Location

• Onsite role in Indianapolis, IN (East side)
• Business casual environment

If you’re looking for a role where your engineering skills directly contribute to patient well-being, while also enjoying a supportive and balanced workplace, this could be the right move for you.

Job Title: Validation Engineer

Location: Gurnee, IL

Hire Type: Long-term Contract, Onsite

Pay Range: $50-70/hour (W2, with full employee benefits)

Employment Type: W2 Only (No C2C)

General Summary

The Validation Engineer is responsible for supporting validation activities related to equipment, automation systems, processes, and facilities within a regulated medical device environment. This role ensures that systems and processes comply with FDA, ISO, and other applicable regulatory requirements while driving improvements in efficiency, safety, and product quality.

Key Responsibilities

Validation Activities: Develop, execute, and maintain validation protocols (IQ, OQ, PQ) for equipment, automation systems, utilities, and processes.

Automation Systems: Support validation of automated manufacturing and laboratory systems, including PLC- and SCADA-based systems, robotics, and process control systems.

Documentation: Prepare and review validation documentation including protocols, summary reports, standard operating procedures (SOPs), and risk assessments.

Compliance: Ensure validation activities meet FDA, ISO 13485, cGMP, and other applicable medical device regulatory requirements.

Process Improvements: Collaborate with cross-functional teams to identify and implement improvements to validation processes and systems.

Troubleshooting & Investigations: Support root cause investigations, corrective and preventive actions (CAPA), and deviation management related to validation.

Project Support: Participate in commissioning, qualification, and validation efforts for new equipment and automation projects.

Requirements

Professional Experience:

3–5 years of validation experience in the medical device, pharmaceutical, or biotech industry.

Hands-on experience with equipment and automation system validation.

Knowledge of FDA QSR, ISO 13485, and cGMP regulations.

Education:

Bachelor’s degree in Engineering, Life Sciences, or related technical field.

Technical Skills:

Proficiency in automation and control systems (e.g., PLCs, SCADA, DeltaV, or equivalent).

Strong technical writing and documentation skills.

Familiarity with risk-based validation approaches and GAMP 5 guidelines.

Other Requirements:

Strong analytical, organizational, and communication skills.

Ability to work independently and as part of a cross-functional team.

Must be authorized to work in the United States on a W2 basis (no C2C).