Computer System Validation (CSV) Specialist - Laboratory Equipment Employment Type:
Contract Computer System Validation (CSV) Specialist - Laboratory Equipment
Primary Duties
:
We are seeking a highly skilled and detail-oriented Computer System Validation (CSV) Specialist to support the validation and qualification of laboratory instruments and computerized systems within regulated environments. The successful candidate will ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 11, GAMP 5, USP , GxP, GLP, and GCLP.
This position focuses on the validation of laboratory equipment such as Met-One Particle Counters, PCR Plate Readers, Spectrophotometers, Microscopes, Analytical Balances, and related systems that support analytical and quality control operations.
Responsibilities include but are not limited to:
- Develop and execute Computer System Validation (CSV) deliverables, including:
- User Requirements Specifications (URS)
- Risk Assessments
- Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Protocols
- Develop and execute IOQ protocols for instruments
- Traceability Matrices
- Final Validation Summary Reports
- Execute qualification protocols and ensure complete, audit-ready documentation.
- Perform risk-based assessments and data integrity evaluations in alignment with GAMP 5 and 21 CFR Part 11.
- Validate and qualify analytical and laboratory systems, including:
- Met-One Particle Counters
- PCR Plate Readers (QuantStudio, EnVision, etc.)
- Spectrophotometers
- Microscopes and Analytical Balances, and other related QC instruments
- Collaborate with QC, QA, IT, and Engineering teams to plan, schedule, and execute validation activities.
- Manage change control, deviation investigations, and validation efforts.
- Ensure compliance with data integrity principles and internal SOPs throughout the equipment lifecycle.
Education and Experience Requirements:
- Bachelor's Degree in Science, Engineering, Computer Science, or a related technical discipline.
- 5 years of experience validating laboratory equipment and computerized systems in a regulated pharmaceutical, biotechnology, or medical device environment.
- Strong understanding of:
- FDA 21 CFR Part 11 (electronic records/signatures)
- GAMP 5 validation lifecycle
- USP analytical instrument qualification
- GLP/GCLP and GxP requirements
- Proficiency in developing and executing CSV documentation (URS, IQ, OQ, PQ, IOQ, Risk Assessments, Reports).
- Demonstrated experience with validation of laboratory systems such as particle counters, plate readers, spectrophotometers, analytical balances, microscopes, and LIMS-integrated systems.
- Excellent written communication, technical documentation, and cross-functional collaboration skills.
- Strong attention to detail and commitment to maintaining compliance and data integrity.
- Proficiency with Microsoft Office Suite (Word, Excel, Outlook).
Other Job Requirements:
- Experience with particle counters, plate readers, spectrophotometers, analytical balances, and microscopes.
- Experience with LIMS and electronic validation management systems.
- Working knowledge of instrument control software integration and automation.
Estimated Min Rate: $38.50
Estimated Max Rate: $55.00
What's In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit
https://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice:
https://www.yoh.com/privacy-notice
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YOH Services LLC
401(k)
Oct 24, 2025