Location: Exton, PA (Onsite)
Job Type: Contract
Experience Required: Minimum 3 years
Position Summary
We are seeking a detail-oriented Validation Specialist with a minimum of 3 years of Computer Systems Validation (CSV) experience in a regulated pharmaceutical, biotechnology, or life sciences environment. The successful candidate will support the execution of Periodic Reviews for validated GxP computerized systems to ensure ongoing compliance with FDA regulations, GAMP 5 guidelines, and company quality standards.
This role requires strong analytical skills, experience reviewing quality documentation, and the ability to investigate system changes, deviations, and validation records while accurately completing periodic review documentation.
Key Responsibilities
- Perform Periodic Reviews of validated GxP computerized systems in accordance with company procedures and regulatory requirements.
- Review validation lifecycle documentation including Validation Plans, IQ/OQ/PQ protocols, Validation Summary Reports, and Risk Assessments.
- Research and evaluate Change Controls, Deviations, CAPAs, Incidents, Audit Findings, and system maintenance records.
- Assess the impact of system changes on validated status and determine if revalidation or corrective actions are required.
- Complete Periodic Review forms, reports, and supporting documentation with accuracy and attention to detail.
- Ensure validated systems remain compliant with FDA 21 CFR Part 11, GxP regulations, and GAMP 5 guidance.
- Collaborate with Quality Assurance, IT, Validation, Engineering, and System Owners to obtain required documentation and resolve review findings.
- Identify compliance risks and recommend corrective actions when appropriate.
- Maintain documentation in accordance with Good Documentation Practices (GDP).
- Support internal and external audits by providing validation documentation and review records.
- Bachelor's degree in Life Sciences, Computer Science, Engineering, Information Systems, or a related technical field.
- Minimum 3 years of Computer Systems Validation (CSV) experience within the pharmaceutical, biotechnology, or medical device industry.
- Experience performing Periodic Reviews of validated computerized systems.
- Strong understanding of:
- FDA 21 CFR Part 11
- GxP/GMP regulations
- GAMP 5
- Good Documentation Practices (GDP)
- Experience reviewing:
- Change Controls
- Deviations
- CAPAs
- Validation documentation
- Risk Assessments
- Excellent technical writing, documentation, and organizational skills.
- Strong analytical and investigative abilities with attention to detail.
- Ability to manage multiple reviews simultaneously while meeting project deadlines.
- Experience with Quality Management Systems such as TrackWise, MasterControl, Veeva QMS, ComplianceWire, or similar platforms.
- Knowledge of laboratory systems, manufacturing systems, or enterprise applications including LIMS, Empower, LabWare, Chromeleon, SAP, MES, or ERP systems.
- Experience supporting FDA, EMA, or other regulatory inspections.
- Familiarity with electronic document management systems (EDMS).
- Computer Systems Validation (CSV)
- Periodic Reviews
- GAMP 5
- FDA 21 CFR Part 11
- GMP/GxP Compliance
- Quality Assurance
- Validation Documentation
- Change Control
- CAPA
- Deviations
- Risk Assessment
- Good Documentation Practices (GDP)
- Technical Writing
- Investigation and Root Cause Analysis
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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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