Role: Cleaning Validation Engineer
Location: Dublin
Contract: 12-month contract

€400 daily rate

At Hays Specialist Recruitment, we have a great opportunity for a Cleaning Validation Engineer Operations Specialist to join our Biopharmaceutical client in Dublin on an initial 12-month contract.

In this role of Cleaning Validation Engineer, they will be responsible for cleaning validation activities at a Sterile Drug product Facility. 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.

Key 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/ Tag out) activities where required. · Generation of standardised 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.·

Investigation support using QMS (Quality Management Systems) and troubleshooting for cleaning validation issues.·

Ensuring adherence to governing site and global procedures and regulatory guidelines.

Qualifications & Experience

The successful candidate must possess a Bachelor/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 of working in a drug product filling facility would be advantageous.