Katalyst CRO · 1 month ago
Lead Validation Engineer
Devens, MA
Contract
Onsite
Lead/Staff
8+ years expKatalyst CRO is seeking an experienced and highly skilled Lead Validation Engineer to support validation, quality, engineering, and manufacturing programs within a cGMP-regulated biopharmaceutical environment. The role involves authoring and executing validation protocols, driving investigations, ensuring site compliance, and delivering high-quality documentation to enable the release and sustained performance of critical manufacturing and laboratory systems.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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