Sr. Validation Engineer

We are seeking a highly experienced Senior CQV (Commissioning, Qualification, and Validation) Engineer to join our team. The ideal candidate will possess a robust background in CQV activities for facilities, utilities, and equipment within regulated industries such as pharmaceuticals, biotechnology, or life sciences. With 7-12 years of hands-on experience, this role requires expertise in project execution, protocol development, regulatory compliance, and cross-functional collaboration to ensure all systems meet current Good Manufacturing Practices (cGMP) standards.

Key Responsibilities:

1. Facilities Qualification:
• Conduct and oversee Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of cleanrooms, HVAC systems, and controlled environments.
• Develop and execute protocols for facility validation including temperature mapping and environmental monitoring.
• Support cleanroom design reviews and commissioning activities.
2. Utilities Qualification:
• Perform and manage qualification activities for critical utility systems such as purified water, compressed air, nitrogen, and process gases.
• Review and redline utility P&IDs, execute system walkdowns, and ensure system readiness for validation.
• Author and review utility-related documents, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and risk assessments.
3. Equipment Qualification:
• Oversee the qualification of process and laboratory equipment such as autoclaves, freezers, cryogenic units, filling stations, biosafety cabinets, and analytical instruments.
• Conduct lifecycle documentation including URS, IOQ, PQ, and validation summary reports.
• Develop traceability matrices to ensure compliance with cGMP and regulatory standards.
4. Project Management & Cross-Functional Collaboration:
• Act as the technical lead for CQV projects, providing expertise to cross-functional teams including engineering, quality, and manufacturing.
• Coordinate with contractors and vendors to ensure timely execution of commissioning and qualification activities.
• Manage validation discrepancies and provide solutions to ensure project timelines are met.
5. Regulatory Compliance and Documentation:
• Ensure compliance with regulatory standards such as FDA, EU GMP, ICH guidelines, and other applicable regulations.
• Author comprehensive validation plans, reports, and standard operating procedures (SOPs).
• Lead audits and inspections related to CQV activities and provide timely responses to findings.

Requirements

Qualifications and Experience:

• Bachelor's degree in Engineering, Biotechnology, or a related technical field.
• 7-12 years of progressive experience in CQV activities within the pharmaceutical, biotech, or life sciences industry.
• Strong understanding of cGMP, FDA, and international regulatory requirements.
• Proven expertise in facility qualification, utility systems, and equipment validation.
• Proficient in project management tools and software (e.g., SmartSheet, Blue Mountain, or equivalent).
• Excellent problem-solving, organizational, and communication skills.

Preferred Skills:

• Experience with automation and computerized systems validation.
• Familiarity with industry-standard validation tools such as Kaye validators, thermocouples, and data loggers.
• Certification in Lean Six Sigma or related methodologies is a plus.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)