4,861 Csv Specialist jobs in the United States

• Computer Systems Validation (CSV) Specialist - Biotechnology

• Timely completion of validation activities, adhering to project schedules and regulatory deadlines
• Maintenance of audit-ready documentation and successful audit outcomes
• Continuous enhancement of validation practices to support compliance and efficiency

• Provide CSV support for VEEVA eQMS (Change Control, CAPAs, Deviations) and initial LIMS phase.

• Contribute to Oracle ERP phase 2 and Master Control EBR implementations.

• Support CSV for Trace link and serialization software integrations.

• Collaborate with teams to ensure smooth progression and compliance across projects.

• Strong CSV background, with experience in Veeva, Master Control, Oracle ERP, and LIMS.

• Familiarity with SaaS applications and cloud-based environments.

• Excellent soft skills for team collaboration.

Job Description

VTI Life Sciences (VTI)  is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry.

We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that computerized systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), and company policies. The role includes the development and execution of validation protocols, risk assessments, and documentation to support the lifecycle of cGxP systems.

RESPONSIBILITIES:

• Authoring and Executing Software Test Protocols.
• Draft, route, and execute Commissioning and Qualification Protocols (CQ, IQ, OQ, PQ) with Final Report.
• Scheduling and execution of qualification activities
• Qualification data collection and analysis against acceptance criteria.
• Drafting and/or reviewing User Requirement Specifications/Software Requirement Specifications.
• Software Design Specification drafting and review.
• Documentation generation and updates (SOPs, PFMEA, Forms, etc.)
• Meeting attendance and project coordination.
• Provide all services in accordance with FDA cGxP guidelines and regulations.

• Bachelor's degree or higher in Engineering, Life Sciences, or related discipline.
• 5+ years of relevant FDA-regulated industry experience.
• Expertise in regulatory requirements and guidance, including 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.
• Familiarity with Python and Test Scripts.
• 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation.
• Must have experience working in an FDA-regulated environment.
• Experience with Automation Equipment such as HMI's, Robotized Manufacturing Systems and Vision Sensors. Experience in manufacturing and testing of Medical Devices.
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
• Exceptional technical writing, review and analytical skills.
• Knowledge of good documentation practices and cGMP.

SALARY RANGE FOR THIS ROLE IS $80,000 - $105,000 ANNUALLY FOR A W2 EMPLOYEE

VTI Life Sciences  strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI  offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI  is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees.

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Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

As the Director, IT Computer System Validation & Quality Assurance, you will play a pivotal role in ensuring the compliance, reliability, and quality of our computer systems within the biotechnology domain. This position offers a unique opportunity for an experienced professional to lead and make a significant impact on our company's success.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Millbrae, CA office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

The ideal candidate for this role should possess experience in computer system validation and quality assurance within the biotech or pharmaceutical industry and demonstrate in-depth knowledge of regulatory requirements such as FDA and GxP pertaining to computer system validation and quality assurance. Proficiency in writing validation documentation, along with exceptional analytical and problem-solving skills, is essential. Strong leadership and communication skills are also critical for providing leadership to the Quality Assurance team and ensuring compliance with industry standards and regulatory demands in computer system validation and quality assurance.

What You'll Do

• Define and drive the global strategy for CSV and software QA aligned with regulatory standards and company goals.
• Establish governance for validation lifecycle management, including system risk assessments, validation planning, testing, and periodic reviews.
• Collaborate with IT, Clinical, and Regulatory teams to ensure compliant and robust software systems.
• Own and evolve the organization's CSV framework across GxP and non-GxP systems.
• Ensure that validation activities meet regulatory and business requirements for systems like Veeva Vaults, QMS, Safety systems and custom applications
• Develop and execute strategies for the validation of computer systems, ensuring compliance with industry standards, regulatory requirements, and company policies.
• Establish and maintain validation protocols, including test scripts, plans, and reports.
• Provide leadership and direction to the Software Quality Assurance team, fostering a culture of quality excellence.
• Collaborate with cross-functional teams to ensure that computer systems meet quality standards and perform efficiently.
• Create, review, and maintain comprehensive documentation related to computer system validation activities.
• Prepare validation reports and documentation for regulatory submissions and audits.
• Design and oversee the execution of test cases to verify the functionality and performance of computer systems.
• Identify and document deviations, issues, and discrepancies encountered during testing.
• Identify opportunities for process optimization and efficiency improvements in computer system validation and quality assurance.
• Develop and deliver training programs for relevant stakeholders.
• Stay current with industry regulations and standards related to computer system validation and quality assurance.
• Ensure audit readiness for internal and external inspections (e.g., FDA, EMA, etc.).
• Assist in regulatory inspections and audits as required.

• Post Graduate degree with 10+ years of experience or a bachelor's degree with 12+ years of experience in Computer Science, Information Technology, Engineering, or a related field. Master's degree is a plus.
• A minimum of 10+ years of experience in computer system validation and quality assurance within the biotech or pharmaceutical industry.
• In-depth knowledge of regulatory requirements (FDA, GxP, GAMP, etc.) related to computer system validation and quality assurance.
• Strong experience with CSV in GxP environments, including risk-based validation approaches.
• Experience working with Veeva Development Cloud Vaults and Commercial solutions
• Familiarity with software development methodologies (Agile, Waterfall, V-model).
• Proficiency in writing validation documentation, including protocols, reports, and procedures.
• Exceptional analytical and problem-solving skills with meticulous attention to detail.
• Strong leadership and communication skills, with the ability to collaborate effectively with cross-functional teams.

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

Youngstown, OH, US

Job Summary:

Quality Assurance Technicians are responsible for identifying and communicating any defects on product. This position involves conducting various sampling and measuring tests in order to ensure the product is meeting customer specifications and is consistent. This position shall communicate with the Production Manager, operators on all lines.

Job Duties:

• Conduct product sampling and testing to ensure cans are within customer specifications and consistent production is being met.

• Perform product sampling and testing such as metal exposure testing, coating adhesion and abrasion resistance, burst and buckle performance and overflow capacity and particulate identification and measurement.

• Inspect barcodes, text and graphics.

• Sample and select product for retain storage.

• File proper paperwork such as start-up sheets.

• Input product and process data.

• Collect pre-delivery samples (PDS).

• Perform finished goods inspection.

• Authority to stop and/or modify work processes due to non-conformance and/or unsafe working conditions.

• Report all potential food safety concerns to the quality assurance manager.

• Perform all other job duties as assigned.

Qualifications and Experience Requirements:

• Previous ISO/GMP and in process testing experience

• Excellent color detection skills and attention to detail

• Measuring skills using calipers, micrometers, gauges, etc.

• Computer skills such as Windows operating system, Microsoft Word, Excel, etc.

• Ability to remain organized and problem solve.

• Must be a team player and possess a "can do" attitude.

• Ability to walk or stand for periods of time.

• Excellent communication skills with the ability to read, write and communicate fluently in English.

Work Environment:

This position performs job duties located on the shop floor. This position walks through the manufacturing floor where machinery produces loud noises. In addition, this position will use quality assurance equipment, telephones/walkie-talkies to perform job duties.

Nearest Major Market: Cleveland

Nearest Secondary Market: Youngstown

• Develop and implement the global GMP & CSV QA strategy aligned with corporate goals, Ideaya SOPs and global regulatory requirements.
• Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards.
• Develop procedures and work flows to define key Quality Systems including Deviation, CAPA, Change Control and Document management. Ensure that cGMP departments and Operating units within Ideaya have written procedures to support GxP activities.
• Oversee the development, implementation, and maintenance of GMP QA policies, quality agreements, standard operating procedures, and quality systems processes and workflows to manage quality events.
• Manage and oversee all aspects of GxP quality functions for clinical and commercial products i.e., Lot Release, Quality Systems records (i.e., Deviations, Change Control, Complaints, Audits, Product Quality Review).
• Monitor emerging regulatory trends and ensure proactive adaptation of QA processes.
• Compile, track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis.
• Lead and manage GMP audits programs (internal and external), including manufacturing sites, contract manufacturers and packagers, suppliers, and laboratories.
• Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings. Represent GMP QA in regulatory inspections, partner audits, and due diligence activities.
• Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events.
• Lead or oversee the annual product quality review (APQR) process to ensure ongoing evaluation of product quality and compliance.
• Drive continuous improvement initiatives based on key performance indicators (KPIs), APQR findings and trends.
• Identify, assess, and mitigate GMP-related risks across the supply chain (end to end), GMP vendors and manufacturing processes.
• Provide expert guidance on GMP & CSV compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management.
• Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and drive continuous improvement.
• Build, mentor, and lead a high-performing GMP & CSV QA team. Foster a culture of quality, accountability, and collaboration within the team and across the organization.
• Partner with CMC, regulatory affairs, IT and R&D to ensure alignment on quality and compliance objectives.
• Support the development and review of batch records, specifications, test methods, protocols, and other critical documents.
• Oversee the selection, qualification, and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories.
• Ensure vendor compliance with contractual obligations, quality agreements and regulatory requirements.

• Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).
• Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years in GMP QA or manufacturing quality roles working in a firm with in-house manufacturing.
• Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities.
• Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes.
• Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs.
• Exceptional leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities.
• Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.
• Strategic thinker with a focus on continuous improvement and innovation.
• This role may require occasional travel (up to 20%) for audits, inspections, and meetings.

• Prior supervisory or function management experience is required.

• Complete all tasks as assigned by the Quality Department Leadership
• Perform all necessary quality audits on production activities
• Report any identified issue to appropriate personnel for prompt resolution
• Provide first-level support to Production Associates on various quality matters
• Provide training to Production Associates regarding product quality
• Perform data entry activities for different quality data reports as required in a timely and efficient manner
• Assist in developing and maintaining of Quality records and retention
• Communicate effectively with team leaders, supervisors and associates on other shifts regarding pertinent issues
• Provide support and communicate effectively with external Customer, Field Sales, Marketing, and Warranty personnel
• Work closely with departmental supervisor on priorities to eliminate obstacles that would prevent product in getting to the customer in a timely manner
• Provide support as needed to ensure 100% accuracy and ensure customer satisfaction
• Responsible for quality, productivity and safety in all given assignments
• Perform other related duties and assignments as required
• 2, 2, 3 Schedule : Night Shift from 7 PM to 7 AM

• Have experience in conducting Root Cause Analysis
• Experience with operating manufacturing equipment and hand tools
• Ability to perform housekeeping duties as needed
• Ability to read a tape measure & Using Caliper
• Basic reading and math skills are preferred
• Ability to lift up to 50 pounds on a continual basis above shoulder height and below the waist
• Ability to perform tasks requiring repetitive motion and stand for long periods
• Possess communication, teamwork, problem-solving, and leadership skills
• Detail oriented
• Basic uses of a Computer
• Must be 18 years or older to apply

• Use manual and programmable measurement tools to gather mechanical and dimensional data
  
• Read and interpret technical drawings to verify product compliance
  
• Operate and program automated testing systems
  
• Apply geometric principles to calculate inferred specifications
  
• Maintain high accuracy when using precision measuring tools
  
• Prepare documentation such as compliance reports, data sheets, and quality analysis
  
• Follow ISO 9001 quality standards and participate in internal audits
  
• Investigate defects and contribute to continuous improvement initiatives
  
• Maintain a clean, safe, and organized work area
  

• Mechanical aptitude and a strong attention to detail
  
• Ability to read and understand technical drawings
  
• Experience using precision dimensional measurement tools
  
• Willingness to learn and operate automated inspection equipment
  
• Knowledge of geometric dimensioning and tolerancing (GD&T) principles
  
• Familiarity with quality standards in industries such as aerospace, defense, or medical preferred
  
• Ability to create accurate, well-organized documentation and reports
  
• Commitment to safety, quality, and continuous improvement within ISO 9001 standards
  
• Eagerness to learn and grow within a quality-focused role
  

• Full Time
  
• Pay Rate is $ 17-21per hour
  
• Shift 1st 8a-430p
  
• Weekly pay while employed through Career Concepts
  
• Benefits available while employed through Career Concepts
  
• Temp-To-Hire
  
• Benefits after Probation period
  

• McKees Rocks, PA
  

Over the past 16 years, with multiple locations in the US, our Client has grown to be one of the lead manufacturers of metal assemblies in the industry. For their customers, both in the commercial and defense industries, our client's goal is to execute each order with a level of detail and dedication that ensures return business, and continued partnerships.With that, our Client invests in their employees, providing a culture, and opportunities, to empower and help them grow as far as their desire will take them.If you are searching for an opportunity that you can turn into a career, and are willing to add to the foundation of an already steady business, then please apply below!We look forward to reviewing your resume! Quality AssuranceStarting Pay Rate: $18 to $20/hourShifts needed: 1st Shift (6.am-3:30p.m)Job DescriptionWe're seeking an experienced quality assurance specialist with an unwavering commitment to meticulous production. The ideal candidate is an exceptionally organized, methodical professional with the experience necessary to take our products to the next level with respect to the accuracy, security, and safety. You will be charged with developing a complete QA program that not only safeguards the quality of our products but also fosters a "quality culture, in which all employees become actively engaged in guaranteeing quality in both production and the finished product.Objectives of this Role Interpret, build upon and comply with company quality assurance standards Carefully maintain a complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions Document quality assurance activities with internal reporting and audits Develop new standards for production and design, with improvements as needed, and create testing protocols for implementation across all service lines Identify training needs and take action to ensure company-wide compliance Pursue continuing education on new solutions, technology, and skills Daily and Monthly Responsibilities Plan, execute, and oversee inspection and testing of the incoming and outgoing products to confirm quality conformance to specifications and quality deliverables Assist operations and local quality function in tracking, documenting, and reporting quality levels as well as CSR, environmental and health and safety goals/KPIs Analyze and investigate product complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements Develop or update company complaint and inspection procedures to ensure capture and investigation, as well as proper documentation of complaints Monitor risk-management procedures, and maintain and analyze problem logs to identify and report recurring issues to management and product development Provide training and support to the quality assurance team on systems, policies, procedures, and core processesSkills and Qualifications High School Diploma required, Associates Degree in Technical Field is a plus Professional certification, such as Six Sigma, Quality Engineer, or Quality Auditor is a definite plus Superb computer competence, including database management Knowledge of quality assurance terminology, methods, and tools Analytical, problem-solving, and decision-making skills Demonstrated knowledge of testing best practices, version control practices, and defect management practiceNesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, veteran status, or any other legally protected characteristics with respect to employment opportunities.