Biopharma Cleaning Validation Engineer - Dublin (12M)

QCS Staffing; Dublin; On-site; EUR 60,000 - 90,000; Full time

Job summary

QCS Staffing in Dublin, Ireland, is seeking a Cleaning Validation Engineer for a 12-month contract. You will develop and implement cleaning validation strategies for new equipment and processes within a leading biopharma facility.

You will execute validation studies, perform risk assessments, and ensure compliance with FDA/EMA/ICH/PDA standards while collaborating cross-functionally on PQs and new product introductions in the SDP manufacturing site.

Qualifications

• Bachelor/Master’s in engineering or science.
• Previous cleaning validation experience is an advantage.
• Strong knowledge of regulatory requirements (FDA, EMA, ICH, PDA).
• Ability to work independently and as part of a team.
• Biopharmaceutical Process / Validation knowledge.

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 compliance with regulatory requirements (FDA, EMA) and industry standards (ICH, PDA).
• Lead cleaning validation studies, process performance qualification and new product introductions in the SDP manufacturing facility.

Skills

Regulatory knowledge

Independent worker

Team collaboration

Biopharma process/validation knowledge

Education

Bachelor/Master's in Engineering or Science

Job description

QCS Staffing in Dublin, Ireland, is seeking a Cleaning Validation Engineer for a 12-month contract. You will develop and implement cleaning validation strategies for new equipment and processes within a leading biopharma facility.

You will execute validation studies, perform risk assessments, and ensure compliance with FDA/EMA/ICH/PDA standards while collaborating cross-functionally on PQs and new product introductions in the SDP manufacturing site.