12 month contract (potential of extension)
On site - Denmark
Senior CQV Engineer - SIP Project


Our client currently has a team of CQV engineers onsite who are responsible for providing C&Q expertise to support on site facility design, start-up and routine commercial manufacturing. We are currently recruiting for additional support for this team in Denmark.

The ideal candidate would have 10-15 years experience in CQV including SIP start up experience in a biopharmaceutical environment.

Responsibilities

• Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained site wide.
• Ensure project related work is carried out in accordance with the requirements of the clients validation policies, guidelines, validation plans and GMP.
• Provide on the floor support for troubleshooting cleaning verification/validation related issues and to lead manufacturing investigations into process deviations.
• Generation of reports / analysis of data against pre-determined criteria to GMP standards.

• Minimum of 8 years’ experience in CQV and SIP Start up within bio-pharmaceutical industry
• Possession of interpersonal, team work and communication skills
• Demonstrated track record in the delivery of goals and improvements
• This role is open to candidates from EU and UK
• Desire to relocate or travel