Senior Computer System Validation Analyst

Job Title: Senior Computer System Validation Analyst

Job Location: West Point, PA

Job Type: Contract

Pay Range: $45.00hr - $50.00hr

Job Overview:

The candidate will provide hands-on experience supporting validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment. The successful candidate will provide CSV compliance support for Capital and Strategic Projects to ensure continuity of compliance oversight and project delivery. The candidate will develop, review, and approve validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.

Responsibilities:

The successful candidate will provide hands-on support for validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment.

The candidate will provide CSV compliance support for Capital and Strategic Projects to ensure continuity of compliance oversight and project delivery.

The candidate s responsibilities include developing, reviewing, and approving validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.

The successful candidate will provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, and change control processes.

Requirements:

The candidate should have strong experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical or manufacturing environments.

The candidate must possess knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA, and Risk Management.

The successful candidate will have experience reviewing and approving validation documentation and compliance deliverables.

The candidate should have familiarity with GxP regulations, Data Integrity, FDA, EMA, and industry compliance requirements.

The candidate should have exposure to one or more manufacturing automation platforms including:

• DeltaV DCS.
• PLC systems (Rockwell and/or Siemens).
• Process Historians.
• Laboratory Automation Systems.

Qualifications:

The candidate must have experience with validation, qualification, change control, risk assessments, and lifecycle compliance activities associated with manufacturing and laboratory computerized systems.

The candidate should have a strong understanding of GxP, Data Integrity, CSV/CSA, and SDLC requirements for manufacturing automation platforms.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities