Senior QA Validation Specialist

Location
:
Full Onsite in Spring House, PA. for first 3 months, then once trained, will be hybrid.

Hiring Method: 1 Year Long Contract - with extensions

Shift: 1st Shift (M-F)

Compensation: $65/hr to $85/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

This role is intentionally designed for someone who:

• Is comfortable working from user intent and regulatory expectations when no off‑the‑shelf solution exists
• Can author clear, defensible User Requirements and IOQ strategies rather than waiting for vendors to provide them
• Knows how to influence vendors who are not GMP‑mature and guide them toward compliant outcomes
• Thrives in design‑phase ambiguity
  , but executes validation activities with precision and structure

If you prefer step‑by‑step instructions already written for you, this role will not be a fit.

• Partner with Engineering, Automation, IT, and Equipment Vendors during functional design to translate manufacturing and lab needs into clear, testable User Requirements (URS)
• Actively shape system design where no pre‑validated or off‑the‑shelf solution exists
• Challenge vendor proposals and documentation to ensure GMP, Annex 1, Annex 11, and 21 CFR Part 11 compliance
• Drive risk‑based qualification strategies for highly automated and integrated systems

• Author and/or review IOQ protocols
  , traceability matrices, risk assessments, and validation plans
• Lead equipment and system lifecycle qualification from design through release
• Review, approve, and influence vendor‑generated documentation when it does not meet GMP or site expectations
• Perform Quality approval of:
• IOQ protocols and reports
• Change controls
• SOPs and lifecycle documentation
• Execute equipment and system release decisions based on compliance, not convenience
• Serve as a quality authority in discussions with equipment manufacturers, automation integrators, and system vendors
• Provide clear guidance to vendors unfamiliar with GMP environments
• Orchestrate qualification activities for interconnected, robotic, and automated systems (systems must “talk” to each other)
• Communicate effectively with installation teams during equipment arrival and commissioning

• Support Level 2 systems and their interfaces with DeltaV
• Ensure compliance with:
• 21 CFR Part 11
• Annex 11
• Annex 1 (Advanced Therapy context)
• Support lab systems including Green Button Go

• 3+ years in Computer System Validation (CSV) or Quality oversight of CSV
• 5+ years total GMP pharmaceutical experience with strong data integrity exposure
• Hands‑on Delta
  
  V experience in regulated environments
• Proven experience developing User Requirements (URS) when vendor solutions are incomplete or non‑standard
• Demonstrated experience authoring or heavily influencing IOQ documentation
• Strong understanding of equipment and system lifecycle management
• Experience qualifying GxP manufacturing and lab equipment
• Comfort navigating electronic quality systems (change control, documentation, validation repositories)

• Experience working on new facility builds or major expansions
• History of working with non‑GMP‑mature vendors and guiding them to compliance
• Exposure to: