Lead Validation Engineer

Lead Validation Engineer – Katalyst CRO, Devens, MA

Join to apply for the Lead Validation Engineer role at Katalyst CRO. This position supports validation, quality, engineering, and manufacturing programs within a cGMP-regulated biopharmaceutical environment.

• 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 (e ) 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 expertise for cleaning validation, equipment qualification, and site validation programs.
• Maintain adherence to FDA, EMA, and ICH guidelines as well as internal site procedures.

• Bachelor's degree in Biochemistry, Chemical Engineering, Life Sciences, or related scientific or engineering discipline.
• 8+ years of experience in validation, CQV, quality assurance, tech transfer, or manufacturing within a GMP-regulated biopharmaceutical environment.
• Expertise in cleaning validation, equipment qualification, utility qualification, deviation investigations, CAPA development, and 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 e , 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.

Location:

Devens, MA (other locations available)

Employment Type:

Contract

Seniority Level: Mid‑Senior level