Job Title
Lead Cleaning and Validation Engineer
Requisition
JR000015777 Lead Cleaning and Validation Engineer (Open)
Location
College Park, Dublin - IRL006
Additional Locations
Job Description Summary
Reporting to the Engineering Services Lead, the Snr Cleaning and Validation Specialist is responsible for leading cleaning and cleaning validation activities to ensure process equipment in manufacturing area remains in a validated state and compliant with GMP, internal procedures, and regulatory expectations. This role plans and coordinates cleaning validation lifecycle work (strategy, execution, reporting, and ongoing monitoring), provides day-to-day technical leadership, and partners with Operations, Engineering, QC, QA, and external vendors to resolve issues and continuously improve cleaning processes.
Job Description
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Own and execute the cleaning validation program for assigned equipment in line with site Validation Master Plan and global standards.
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Support and maintain the site Validation Master Plan (VMP) for cleaning validation.
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Define and implement cleaning validation strategies in compliance with cGMP and regulatory requirements.
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Lead cleaning validation activities for new product introductions, process changes, and equipment modifications.
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Develop validation protocols, define sampling strategies, oversee validation runs, and issue validation reports.
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Investigate deviations/non-compliance events, perform impact assessments, and propose corrective actions (CAPA).
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Update cleaning procedures and validation documentation as required.
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Act as Subject Matter Expert (SME) during audits and inspections and drive continuous improvement initiatives.
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Lead execution of cleaning validation protocols (IQ/OQ/PQ) for process equipment and manufacturing systems.
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Work cross-functionally with engineering, quality and manufacturing teams during start-up activities.
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Lead cross-functional planning for validation activities (scheduling, resources, line clearance, access, and readiness) to support manufacturing timelines.
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Provide technical oversight during execution: field verification, sample collection coordination, deviation containment, and on-the-floor coaching.
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Review and trend cleaning data and environmental/bioburden/endotoxin results (as applicable) to support continued process verification and maintaining the validated state.
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Initiate, investigate, and drive closure of deviations, nonconformances, and CAPAs related to cleaning/cleaning validation.
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Assess and approve change controls impacting cleaning processes, equipment, detergents/disinfectants, recipes, cycle parameters, and campaign strategies; determine validation impact and required testing.
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Support qualification of cleaning equipment (e.g., CIP/SIP skids, parts washers) and cleaning-related utilities and controls.
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Manage or support third-party validation/cleaning service providers, including scope definition, oversight, and review/approval of deliverables.
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Maintain site cleaning validation procedures, forms, and training materials; ensure personnel are trained and compliant.
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Prepare for and support regulatory inspections and internal audits; present program status, rationale, and evidence of control.
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Drive continuous improvement initiatives (cycle optimization, right-first-time documentation, visual inspection enhancements, digitization, and risk-based validation).
Job Requirements:
- Bachelor’s degree in Science/Engineering (Chemistry, Biochemistry, Microbiology, Chemical Engineering, Pharmaceutical Sciences) or equivalent experience – Preferred
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Typically 5+ years’ experience in a GMP regulated manufacturing environment (pharmaceutical, biotech, medical device, or similar), with 3+ years focused on cleaning validation and/or process/equipment validation.
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Working knowledge of regulatory expectations and guidance relevant to cleaning and validation (e.g., EU GMP Annex 15, FDA process validation guidance, ISPE baseline guidance, data integrity principles).
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Proven experience authoring and reviewing validation documents to a high compliance standard.
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Demonstrated ability to lead cross-functional activities and influence without authority in a fast-paced operations setting.
Preferred:
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Strong understanding of cleaning science: residues/solubility, detergents/disinfectants, contact time, temperatures, mechanical action, and equipment design considerations.
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Risk-based validation approach and sound scientific/technical judgment.
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Excellent documentation skills (GDP), attention to detail, and ability to write clear, defensible rationales.
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Data analysis and trending (e.g., spreadsheets, basic statistics) to support continued verification and improvements.
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Investigation and problem-solving skills (root cause analysis tools such as 5-Why/Fishbone).
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Stakeholder management and clear communication with Operations, QA/QC, Engineering, and suppliers.
At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.
We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.
We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.
