Cleaning Validation SME

Summary:

Our client, a biopharmaceutical company located in East Cork, is seeking a Cleaning Validation SME. The successful candidate will provide specialist leadership for cleaning validation across process equipment and systems, supporting activities from design and qualification through to start-up, handover and the continued validated state.

Responsibilities:

• Act as the Cleaning Validation subject matter expert, providing technical leadership from design through commissioning, qualification, start-up and handover.
• Execute and maintain the cleaning validation programme and associated lifecycle documentation in accordance with site procedures and regulatory expectations.
• Prepare, review and execute cleaning validation risk assessments, protocols, sampling plans, acceptance criteria, reports and associated procedures.
• Review user requirements, design documentation, process descriptions, equipment specifications, commissioning plans and qualification protocols from a cleaning validation perspective.
• Lead assessments of product and equipment cleaning requirements, including equipment grouping, product grouping or bracketing, worst-case selection and validation rationale.
• Assess hygienic design, drainability, cleanability, sampling access and inspection requirements, identifying gaps requiring remediation.
• Establish scientifically justified residue limits and acceptance criteria with Quality, Toxicology and relevant technical functions, including health-based exposure limits where applicable.
• Define and justify sampling locations and methods, including swab, rinse and visual inspection approaches, and ensure recovery studies and analytical method requirements are addressed.
• Coordinate with analytical laboratories and technical teams to ensure suitable analytical methods are available and appropriately validated or verified before execution.
• Plan and coordinate cleaning validation execution, including resources, equipment and product availability, sampling, laboratory support and schedule integration.
• Provide field oversight, support cleaning sample collection and ensure deviations, atypical results, observations and protocol changes are assessed, documented and resolved.
• Analyse validation data, identify trends and prepare technical conclusions demonstrating that cleaning processes are effective, repeatable and suitable for routine operation.
• Lead investigations into cleaning validation failures or adverse trends, applying root-cause analysis and defining corrective and preventive actions.
• Support commissioning and qualification activities, including IQ, OQ and PQ, to confirm cleaning functionality and critical parameters are adequately challenged and documented.
• Provide cleaning validation input to process validation, manufacturing readiness, engineering batches, commercialisation plans, change controls and quality risk assessments.
• Work with Operations and Training to develop routine cleaning procedures, training requirements, continued verification activities and ongoing monitoring expectations.
• Support inspection readiness, internal audits, regulatory inspections and quality reviews relating to cleaning validation.
• Ensure compliant handover of cleaning validation documentation, knowledge and ownership to the receiving site functions.
• Complete required vessel-entry and confined-space training and safely perform activities requiring vessel access.

Qualifications & Experience:

• Bachelor’s degree in Chemical Engineering, Process Engineering, Mechanical Engineering, Pharmaceutical Science, Chemistry, Microbiology or a related technical discipline.
• Significant validation experience within a pharmaceutical, biotechnology or medical-device GMP manufacturing environment, including ownership or leadership of cleaning validation programmes.
• Working knowledge of EU GMP Annex 15, PIC/S PI 006, PDA Technical Reports and ISPE guidance.
• Strong knowledge of cleaning validation lifecycle principles, risk-based approaches, residue limit setting, worst-case selection, recovery studies, sampling strategies and analytical method requirements.
• Experience developing and executing cleaning validation strategies for product-contact equipment, vessels, transfer lines, clean-in-place systems and manually cleaned equipment.
• Practical experience authoring and approving validation plans, risk assessments, protocols, sampling plans, deviations and final reports.
• Strong understanding of GMP, data integrity, Good Documentation Practice and validation expectations for cleaning processes and process equipment.
• Experience supporting capital projects through design, FAT/SAT, commissioning, qualification, start-up and operational handover.
• Ability to interpret process and equipment drawings, piping and instrumentation diagrams, equipment specifications and control narratives from a cleanability and validation perspective.
• Experience working with analytical laboratories and technical specialists on residue methods, sampling recovery and result interpretation.
• Ability to lead cross-functional teams, influence technical decisions and manage interfaces across Engineering, Quality, Operations, C&Q, Technical Operations, Microbiology and external vendors.
• Proficiency with Microsoft Office and relevant electronic quality, document-management or validation systems.
• Experience with solution preparation, formulation or other liquid biopharmaceutical manufacturing processes is desirable.
• Experience with health-based exposure limits, toxicological assessments, automated CIP systems and continued cleaning verification programmes is desirable.