Validation Engineer

Validation Engineer – Katalyst CRO

Join the team as a mid-level CQV Engineer supporting pharmaceutical manufacturing facility projects. Field-based execution role focused on commissioning and qualification activities.

• Assist in implementing acceptance criteria, specifications, root cause analysis and corrective action plans.
• Collaborate with Engineering, QA, Automation, and construction teams to ensure systems are delivered per GMP and project standards.

• AHUs and Cleanroom HVAC systems.
• Water for Injection (WFI).
• Clean steam.
• Compressed air and process gases.
• CIP/SIP systems.

• Fermenters.
• Chromatography skids.
• Tangential Flow Filtration (TFF) units.
• Buffer prep and hold tanks.
• Centrifuges.
• Formulation vessels and associated skids.
• Parts Washers.
• Autoclaves.
• HPLC.
• Lyophilizer.

• Experience with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Bachelor's degree in Engineering or related technical field.
• 5+ years of commissioning, qualification and validation experience in the pharmaceutical/biotech or medical device industry.
• Experience with qualification, commissioning/decommissioning and validation for process support equipment, automation systems and/or utilities systems.
• Experience with cleaning validation protocol generation and execution.
• Proficiency with Veeva VMS, Kneat or Val Genesis for protocol development, execution and documentation.
• Familiarity with P&IDs, engineering and source documentation (URS, FS, Owner's Manual) and protocol execution standards to generate detailed test scripts.
• Clear written and verbal communication, collaborative mindset and ability to work autonomously within cross‑functional teams.
• Ability to independently perform basic troubleshooting to resolve setup, testing, protocol discrepancies and propose solutions.

• Project experience in greenfield or facility expansion projects.
• Experience with equipment controlled by building management or automation system (Delta
  
  V, SCADA, Rockwell PAx).
• Experience using commissioning tracking tools or turnover documentation systems.
• Cleaning validation of process equipment, including cleaning cycle development, rinse sampling, surface swabbing, visual inspections.
• Experience executing Computer Software Assurance (CSA) testing for manufacturing process equipment.
• Experience performing periodic reviews to evaluate and requalify validated state.