C&Q (Commissioning & Qualification) Engineer

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce

Currently we are looking for a C&Q Engineer for one year.

The position will report to the C&Q Manager and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:

- Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- Qualification/Validation Master plans are up to date and established for all ongoing projects
· Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment
· Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
· Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
· Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
· Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners
· Coordination and oversight of external suppliers
 

Qualifications:

· Bachelor/Master's degree in technical or natural sciences
· A minimum of 3 years of working experience within pharma company in C&Q/CQV equivalent position
· Know-how of Qualification requirements according to cGMP regulations
· Experience working with cross-department stakeholders
· Know-how of quality assurance principles
· Experience working in project teams and multiple projects in parallel
· Experience working with ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
· Excellent communication skills
· Analytical thinking and problem-solving ability
· Business fluency in English
· German language is a plus
· Self time management

If you are interested in hearing more about our C&Q Engineer role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!