What are the responsibilities and job description for the Lead Validation Engineer position at Katalyst Healthcares and Lifesciences?
Job Details
Job Summary:
Roles & Responsibilities:
Validation & CQV Execution
Education & Experience:
- 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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