Manager, Commissioning

vor 2 Wochen

Bern, Schweiz Emergent Biosolutions Vollzeit

Purpose of this role Ensure efficient qualification processes under the currently applicable requirements and recognized industry best practice Management of the qualification team (Functional and personnel )

To complement and strengthen our Engineering Department we are looking for a

Manager, Commissioning & Qualification (f/m) 100%

**Main Responsibilities**:
Ensure the qualified status of the production site Bern
Lead and develop staff personnel within the C&Q function
Ensure consistent documentation quality in support of both CAPEX and OPEX projects.
Participate in regulatory inspection and response activities.
Initial qualifications of equipment and facilities (e.g., cleanroom facilities, bioprocess equipment, clean utilities)
Manage the execution and documentation of functional tests, protocols, and qualifications for new systems
Complete investigations of process system deviations and implement corrective and preventative actions as required to mitigate future recurrence.

Our Requirements
Management and communication
Leadership experience
Consistent communication with staff, supervisors, within the EBSI organization, and with external authorities and partners
Analytical thinking for problem-solving
Excellent verbal and written communication skills in English and German

Technical
University education (engineer, chemist, biologist, or pharmacist) or equivalent.
Experience in the pharmaceutical environment
Sound knowledge in the area of plant and room qualifications in the GMP environment
Experience in quality assurance (GMP) and the necessary qualification and validation procedures (RA, URS, DQ, IQ, OQ, PQ)
Experience in GEP (Good Engineering Practice)
Inspection experience in the pharmaceutical field

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