Description
Validation Engineer (Cleaning/SIP/CIP)Location - Denmark
Type - initially 3 month contract +
Our client is a leading global Biopharmaceutical company specialising in R&D, therapy development and manufacture.
Key Responsibilities:
• This individual will be involved in the routine validation activities on equipment/cleaning as well as working alongside the new projects and installations.
• Write validation protocols and reports.
• Support on-going validation activities, specifically on IQ/QO validation and (PQ) batch2batch cleaning validation of manufacturing glass washers.
• Co-ordinate validation activities with other stakeholders: sampling scheduling, QC analysis of samples etc.
• Participate in daily co-ordination meetings with production group.
• (PQ) Work in terms of SIP validation of autoclaves and bioreactors where on-hands/on-the-floor experience with KAYE temperature data logging equipment is a must.
• Perform validation field execution (mainly on washers / autoclaves/Bioreactors, when applicable)
Ideal Skills and Experience:
• Degree or HNC/D qualified in an Engineering based subject or related experience in a Validation role.
• Experience within Biopharmaceutical manufacturing environments with specific cleaning validation/process validation experience working within a cell culture environment.
• Equipment experience could include; Bioreactors, filter transfer, mixing tanks, autoclaves and cleaning systems.
• job requires hands-on experience with writing protocols/reports and special test instructions, training and interaction with manufacturing associates as well as people in engineering, metrology and quality departments.
• Cleaning/CIP experience with previous responsibility for generation and reviewing protocols.
• Compilation and development of associated Validation documentation in line with GMP standards.