Lead Validation Engineer

2 weeks ago

Ayer, MA, United States Katalyst Healthcares and Life Sciences Full time
Job Summary:
  • We are seeking an experienced and highly skilled Lead Validation Engineer to support validation, quality, engineering, and manufacturing programs within a cGMP-regulated biopharmaceutical environment.
  • The ideal candidate brings deep expertise in cleaning validation, equipment qualification, CQV, tech transfer support, and quality systems, along with the ability to lead cross-functional teams through complex validation and deviation resolution activities.
  • This role is responsible for authoring and executing validation protocols, driving investigations, ensuring site compliance, supporting regulatory inspections, and delivering high-quality documentation to enable the release and sustained performance of critical manufacturing and laboratory systems.


Roles & Responsibilities:
Validation & CQV Execution
  • Develop and execute validation strategies for cleaning processes, utilities, laboratory equipment, and manufacturing systems in alignment with cGMP, site requirements, and industry standards.
  • Author and execute Cleaning Validation, Clean Hold Time, Dirty Hold Time, Cycle Development, and Equipment Qualification (IQ/OQ/PQ) protocols.
  • Lead CQV activities for new and existing equipment, ensuring compliance with URS, engineering specifications, and manufacturer recommendations.
  • Write, review, and approve validation documents including protocols, summary reports, design documents, SOPs, batch records, and technical evaluations.
  • Create and manage deviations, change controls, investigations, and CAPAs as part of ongoing validation and operational support.
  • Ensure documentation accuracy, completeness, and alignment with regulatory expectations.
  • Troubleshoot and investigate validation protocol exceptions, OOS/OOT results, equipment failures, and cleaning discrepancies.
  • Conduct root cause analyses and develop corrective and preventive actions to prevent recurrence.
  • Collaborate with QA, Engineering, Manufacturing, and Validation leadership to drive timely closure of investigations.
  • Support technology transfer activities, including review of process requirements, generation of process flow diagrams, and gap analyses.
  • Provide on-the-floor support during manufacturing, assisting with real-time troubleshooting of processing issues.
  • Participate in creation and optimization of electronic batch records (eBR) and in-process sampling plans.
  • Analyze manufacturing and validation data to identify process improvements and optimize system performance.
  • Partner with departments including Quality Assurance, Validation, Manufacturing, Process Development, Engineering, and Program Management to ensure successful project execution.
  • Facilitate system release and handover to end users following completion of qualification activities.
  • Provide clear communication of project status, risks, and deliverables to stakeholders.
  • Support regulatory inspections, internal audits, and client audits, providing subject matter expertise for cleaning validation, equipment qualification, and site validation programs.
  • Maintain adherence to FDA, EMA, and ICH guidelines as well as internal site procedures.

Education & Experience:
  • Bachelor's degree in Biochemistry, Chemical Engineering, Life Sciences, or a related scientific or engineering discipline.
  • 8+ years of experience in validation, CQV, quality assurance, tech transfer, or manufacturing within a GMP-regulated biopharmaceutical environment.
  • Cleaning validation, Equipment qualification, Utility qualification, Deviation investigations & CAPA development, Authoring protocols, reports, batch records, and design documents
  • Strong working knowledge of FDA, ICH, and GMP regulations.
  • Experience with large-scale biologics manufacturing equipment (e.g., bioreactors, process vessels, chromatography/UFDF skids, single-use systems).
  • Experience supporting technology transfer activities.
  • Experience with electronic systems such as eBR, QMS platforms, and data analysis tools.
  • Strong problem-solving and analytical skills.
  • High attention to detail and documentation rigor.
  • Ability to manage multiple projects in a fast-paced environment.
  • Effective communicator with strong cross-functional leadership abilities.
  • Flexible, reliable, and committed to delivering high-quality work.

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