Katalyst Healthcares and Lifesciences
Katalyst Healthcares and Lifesciences

Lead Validation Engineer

Devens, MA, US • Posted 60+ days ago • Updated 9 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

👾 Reticulating splines...

Job Details

Skills

  • Quality Management
  • Laboratory Equipment
  • Good Manufacturing Practice
  • IQ
  • OQ
  • PQ
  • Regulatory Compliance
  • URS
  • Root Cause Analysis
  • Collaboration
  • Process Flow
  • Gap Analysis
  • Real-time
  • Optimization
  • Process Improvement
  • Process Engineering
  • Program Management
  • Project Implementation
  • Communication
  • Auditing
  • Biochemistry
  • Chemical Engineering
  • Life Sciences
  • Quality Assurance
  • Corrective And Preventive Action
  • GMP
  • Manufacturing
  • Chromatography
  • Technology Transfer
  • QMS
  • Data Analysis
  • Problem Solving
  • Conflict Resolution
  • Analytical Skill
  • Attention To Detail
  • Documentation
  • Management
  • Leadership

Summary

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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 76688048c1e0db7db051bc341e8f08e4
  • Posted 30+ days ago
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