Validation Engineer

Location: Framingham, MA

About the role

Lead and execute equipment requalification activities to ensure compliance with GMP standards. Prepare and review qualification protocols and reports to maintain quality documentation. Perform IQ/OQ/PQ activities across various production and utility systems. Support Commissioning, Qualification, and Validation (CQV) execution processes. Manage deviations and CAPA linked to qualification activities to foster continuous improvement.

Responsibilities

• Lead and execute equipment requalification activities to ensure GMP compliance.
• Prepare and review qualification protocols and reports.
• Perform IQ/OQ/PQ activities across production and utility systems.
• Support Commissioning, Qualification, and Validation (CQV) execution processes.
• Manage deviations and CAPA linked to qualification activities.

Requirements

• Experience in Equipment Requalification and GMP validation activities.
• Knowledge of IQ/OQ/PQ procedures and documentation.
• Background in Engineering, Utilities & Facilities, and Equipment Lifecycle Management.
• Strong understanding of Deviation & CAPA Management processes.
• Excellent collaboration skills to work effectively with Engineering, Manufacturing, and Quality teams.

Benefits

Upon completion of waiting period, consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

Additional Information

• Opportunity to work on impactful validation projects within a dynamic team.
• Gain valuable experience in GMP compliance and equipment qualification.
• Collaborate with industry experts and enhance your professional skills.
• Immediate start with potential for contract-to-hire conversion.
• Supportive work environment that values diversity and inclusion.