PE Global is currently recruiting for a Cleaning Validation Engineer on behalf of a leading pharmaceutical company based in Dublin North. This is an initial 12 month contract role.
Position Summary
The successful candidate will be part of a multi-functional team charged with the delivery of the significant capital investment and will be responsible for developing, executing, and maintaining cleaning validation protocols and procedures to ensure that manufacturing equipment and facilities meet regulatory standards for cleanliness. Reporting to the Senior Validation Engineering Manager, Sterile Drug Product Manufacturing, Science & Technology.
Responsibilities
Develop and implement cleaning validation strategies for new equipment and processes.
Execute cleaning validation studies, including sampling, testing, and data analysis.
Conduct risk assessments to identify critical cleaning parameters and acceptance criteria.
Ensure that cleaning validation activities comply with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ICH, PDA).
Work cross functionally to lead any cleaning validation studies, process performance qualification and new product introductions in the SDP manufacturing facility.
Plan and coordinate cleaning validation activities with cross-functional teams, including Manufacturing, Quality Control, and Engineering.
Assisting with LOTO (lockout/Tagout) activities where required.
Generation of standardized cleaning validation ECPs (Energy Control Plans).
Investigation support using QMS (Quality Management Systems) and troubleshooting for cleaning validation issues.
Cleaning validation release memos to support product release.
Oversight of the cleaning visual inspection qualification and requalification process on site.
Ensuring adherence to governing site and global procedures and regulatory guidelines.
Education & Experience
The successful candidate must possess a Bachelor or Master’s in engineering, or science related discipline.
Previous cleaning validation experience is an advantage.
Strong knowledge of regulatory requirements and industry standards related to cleaning validation (e.g., FDA, EMA, ICH, PDA).
Ability to work independently and as part of a team.
The ideal candidate would have biopharmaceutical process / validation knowledge.
Exposure to cGMP in a fast‑paced environment is required.
Previous experience in working in a drug product filling facility would be advantageous.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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