Validation Engineer- CAPEX

Position Summary

The Validation Engineer is responsible for the planning, authoring, execution, and reporting of validation activities supporting capital projects and ongoing operations within a cGMP pharmaceutical manufacturing environment. This role ensures that equipment, utilities, facilities, and processes are qualified to meet regulatory and quality standards and are fit for their intended use.

Key Responsibilities

• Develop and execute Validation Master Plans (VMPs), validation strategies, and project-specific qualification plans for capital projects.
  
• Author, execute, and review IQ, OQ, and PQ protocols for process equipment, utilities, clean rooms, CIP/SIP systems, autoclaves, lyophilizers, isolators, and packaging lines.
  
• Perform risk assessments (FMEA, impact assessments, criticality analyses) in alignment with ASTM E2500 and ICH Q9 principles.
  
• Lead computer system validation (CSV) activities in accordance with GAMP 5 for systems including SCADA, DCS, LIMS, MES, and historians.
  
• Coordinate with Quality, Manufacturing, Engineering, and C&Q teams to align validation deliverables with project schedules and quality requirements.
  
• Manage validation deviations, change controls, CAPAs, and impact assessments through the Quality Management System (QMS).
  
• Generate validation summary reports, traceability matrices, and final qualification documentation packages.
  
• Support regulatory inspections (FDA, EMA, MHRA, PMDA) and internal/external audits by providing validation evidence and SME response.
  
• Drive risk-based, lifecycle approaches to validation, reducing redundant testing while ensuring compliance.
  
  

  Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field.
  
• 3–7 years of validation experience in pharmaceutical, biotech, or medical device GMP environments.
  
• Demonstrated experience authoring and executing IQ/OQ/PQ protocols on capital projects.
  
• Strong working knowledge of cGMP regulations (21 CFR Parts 210, 211, 11, Annex 1, Annex 15).
  
• Familiarity with ASTM E2500, ICH Q7/Q8/Q9/Q10, GAMP 5, and ISPE Baseline Guides.
  
• Excellent technical writing and documentation skills.
  
  

  Preferred Qualifications

• Experience with aseptic processing, sterile fill-finish, or biologics manufacturing.
  
• Cleaning validation and process validation (Stage 1/2/3) experience.
  
• CSV and Data Integrity (ALCOA+) experience.
  
• ASQ CQE, CQA, or similar quality certification.
  
  

  Technical Skills

• Validation lifecycle management tools (Kneat, ValGenesis, or equivalent).
  
• Electronic QMS platforms (TrackWise, Veeva, MasterControl).
  
• MS Office, MS Project, and statistical software (Minitab) a plus.
  
  
  
  
  

  Why Join Us

• Work on greenfield and brownfield capital projects supporting next-generation therapeutics.
  
• Exposure to cutting-edge process technologies, single-use systems, and advanced automation platforms.
  
• Collaborative, safety-first, quality-driven culture committed to patient outcomes.
  
  

  Equal Opportunity Employer

  Hydrogen Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
  
  
  
  

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