Senior Validation Engineer

Position Overview

We are seeking an experienced Senior Validation Engineer to lead validation, qualification, and calibration activities supporting capital projects, manufacturing operations, laboratory systems, and regulated processes. This role will serve as a key technical resource responsible for ensuring equipment, utilities, computerized systems, and manufacturing processes meet regulatory, quality, and operational requirements.

The ideal candidate will possess strong expertise in equipment qualification, process validation, computer system validation (CSV), calibration programs, and risk-based validation strategies within GMP-regulated environments. This individual will collaborate with Engineering, Quality, Manufacturing, Operations, and Regulatory teams to drive compliance and successfully execute critical projects.

Key Responsibilities

Validation Strategy & Project Execution

• Lead validation activities from project planning through execution and final approval.
• Develop and maintain Validation Master Plans (VMPs), validation strategies, qualification plans, and validation lifecycle documentation.
• Author, review, and execute IQ, OQ, and PQ protocols, test scripts, validation reports, and traceability matrices.
• Support capital expansion, facility upgrades, equipment installations, and process improvement initiatives.

Equipment Qualification & Calibration

• Lead qualification and calibration activities for manufacturing equipment, laboratory instruments, utilities, and facility systems.
• Ensure calibration programs maintain compliance with internal procedures and industry standards.
• Oversee calibration documentation, traceability requirements, and record management.
• Support commissioning and qualification efforts for new equipment and systems.

Computer System Validation (CSV)

• Execute and support validation efforts for computerized systems including:
  • SCADA
  • DCS
  • MES
  • LIMS
  • Data Historians
  • Laboratory Software Systems
• Ensure compliance with GAMP 5, 21 CFR Part 11, and Data Integrity requirements.

Risk Assessment & Change Management

• Conduct risk assessments utilizing FMEA, impact assessments, and criticality analyses.
• Evaluate changes to equipment, processes, facilities, and software systems to determine validation requirements.
• Apply risk-based validation principles in accordance with ASTM E2500 and ICH guidelines.

Compliance & Regulatory Support

• Ensure validation and qualification activities comply with:
  • FDA regulations
  • cGMP requirements
  • 21 CFR Parts 210, 211, and Part 11
  • ASTM E2500
  • ICH Q7, Q8, Q9, and Q10
  • GAMP 5
• Support regulatory inspections, customer audits, and internal quality audits.
• Prepare validation documentation packages and provide technical responses during inspections.

Cross-Functional Collaboration

• Partner with Engineering, Manufacturing, Quality Assurance, QC, Operations, Automation, IT, and Regulatory Affairs teams.
• Coordinate validation activities with project schedules and business priorities.
• Provide technical guidance and mentorship to junior engineers and validation personnel.

Continuous Improvement

• Identify and implement improvements to validation and calibration programs.
• Drive standardization of validation processes, templates, and best practices.
• Support initiatives focused on efficiency, compliance, and operational excellence.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related technical discipline.
• 5+ years of experience in validation, qualification, calibration, or commissioning within pharmaceutical, biotechnology, medical device, or other GMP-regulated environments.
• Strong understanding of:
  • cGMP regulations
  • FDA requirements
  • ASTM E2500
  • ICH guidelines
  • GAMP 5
  • 21 CFR Part 11
  • Data Integrity principles
• Experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Experience supporting equipment qualification, utilities validation, and manufacturing systems.
• Excellent technical writing, communication, and project management skills.

Preferred Qualifications

• Experience supporting large-scale CAPEX projects.
• Experience with aseptic manufacturing, sterile processing, biologics, or advanced therapy manufacturing.
• Experience with process validation, cleaning validation, and CSV programs.
• Familiarity with validation management platforms such as Kneat or ValGenesis.
• Experience with electronic quality systems such as MasterControl, Veeva, or TrackWise.
• Knowledge of calibration standards, uncertainty analysis, and metrology principles.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant certifications.
• Proven history of supporting successful FDA and regulatory inspections.