Process Validation Engineer

Job Title: Process Validation Engineer
Company: Prowise Solutions
Location: Boston, MA (Onsite 5 Days/Week)
Employment Type: W2 Only

Duration: 12 Months Contract with possible extension.

Rate: $55 to $60/hr on W2.

Job Description

Prowise Solutions is seeking an experienced Clinical Systems / GxP Compliance Consultant to support a leading client in the Pharma/Life Sciences domain. This role requires strong expertise in regulatory compliance and validation to ensure systems remain audit-ready and compliant with global standards.

Key Responsibilities

• Maintain clinical and quality systems in a validated state
• Ensure compliance with GxP regulations, including 21 CFR Part 11 and EU Annex 11
• Support FDA and regulatory audit readiness activities
• Manage and oversee:
• Change Controls
• Deviations
• CAPAs (Corrective and Preventive Actions)
• Periodic Reviews
• Apply ALCOA+ data integrity principles across systems and processes
• Collaborate with cross-functional teams to ensure compliance and documentation standards

Required Qualifications

• Prior experience in Pharmaceutical / Life Sciences industry
• Strong understanding of:
• GxP Compliance
• 21 CFR Part 11
• EU Annex 11
• Hands-on experience maintaining validated systems
• Experience with regulatory inspections and audit support
• Strong documentation and communication skills
• LinkedIn profile required
• Ability to provide professional references upon request

Additional Requirements

• Must be local to Massachusetts or willing to relocate
• Comfortable working 5 days onsite in Boston, MA
• Must be eligible to work on a W2 basis only