Cleaning Validation Engineer.

Summary

Our client, a biopharmaceutical company located in East Cork, is seeking a Cleaning Validation Engineer. The successful candidate will ensure cleaning validation studies are planned and executed right first time. The role will support the establishment and optimisation of robust automated clean-in-place (CIP) and manual cleaning cycles that are repeatable and demonstrably return shared product-contact equipment to an acceptable clean state for the next batch.

Responsibilities

• Plan, coordinate and execute cleaning validation studies in accordance with approved protocols, site procedures and the agreed schedule, with a focus on right-first-time execution.
• Provide practical technical direction on establishing, challenging and improving DCS-controlled CIP recipes and manual cleaning cycles for vessels, transfer lines, hoses, valves, removable parts and associated product-contact equipment.
• Assess product and equipment groupings, cross-contamination risks and cleaning challenges for shared multi-product equipment.
• Select and scientifically justify worst-case representative products, equipment, locations and operating conditions, including appropriate bracketing or matrixing where justified.
• Perform visual inspections and collect representative chemistry and microbiological samples, including surface swabs, bioburden swabs, rinse samples and grab samples, using approved techniques and chain-of-custody requirements.
• Enter vessels or confined spaces for inspection and sampling only when trained, authorised and working under applicable permit, isolation and rescue arrangements.
• Remove, handle, sample and reinstall cleaned product-contact parts within equipment trains using controlled aseptic technique and approved procedures to avoid recontamination.
• Verify prerequisites, equipment status, cleaning parameters, hold times, sampling locations and procedural controls before and during execution. Pause, stop or void a study where procedural compliance or data validity is compromised.
• Review and interpret chemical residue, TOC or product-specific analytical data, conductivity and microbiological or bioburden results against approved acceptance criteria.
• Lead or support investigations into ineffective cleaning, atypical results and false failures using logical, evidence-based root-cause analysis, identifying whether the issue relates to the cleaning process, sampling, laboratory analysis, equipment condition, execution or documentation.
• Prepare clear, accurate and timely protocols, sampling plans, deviations, investigation records, technical assessments and final validation reports supporting an unambiguous conclusion on cleaning effectiveness and repeatability.
• Work with Operations, Engineering, C&Q, Validation, Quality, Technical Operations, Chemistry, Microbiology and vendors to resolve issues and deliver studies to schedule.
• Support the implementation of sustainable routine cleaning instructions, training, change assessment, revalidation triggers and continued cleaning verification requirements.

Qualifications & Experience

• Bachelor’s degree in Engineering, Pharmaceutical Science, Chemistry, Microbiology or a related technical discipline, or an equivalent combination of education and relevant industry experience.
• Approximately 5 years of relevant experience in a pharmaceutical or biotechnology GMP manufacturing environment, with evidence of direct field execution rather than document review alone.
• Experience establishing, executing and troubleshooting both automated CIP and manual cleaning cycles for product-contact equipment.
• Practical experience with shared multi-product equipment and scientifically justified worst-case product, equipment and sampling-location selection.
• Proficiency in collecting chemistry and microbiological samples, including swab, rinse and bioburden samples, and applying correct sample handling and chain of custody.
• Experience interpreting analytical and microbiological results and investigating cleaning failures, atypical results and adverse trends.
• Experience authoring cleaning validation protocols and reports, documenting exceptions or deviations and presenting technically sound conclusions.
• Working knowledge of GMP, data integrity, Good Documentation Practice and relevant cleaning validation expectations, including EU GMP Annex 15, PIC/S PI 006, applicable PDA Technical Reports and ISPE guidance.
• Good knowledge of aseptic technique and contamination-control principles when handling cleaned parts and accessing cleaned equipment.
• The successful candidate must be comfortable working with equipment, collecting chemistry and microbiological samples, entering vessels where authorised, handling cleaned parts using aseptic technique, interpreting results, and stopping or voiding a study where approved procedures or critical execution conditions have not been followed.