Commissioning Manager

View: 191

Update day: 29-03-2024

Location: Bern Bern BE

Category: High Technology Mechanical / Technical Electrical / Electronics Science Labor Production / Operation

Industry: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

A Biotechnology company is searching for a;Commissioning & Qualification Manager

Overview of position:

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

Responsibilities:

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

Requirements:

(Communication & Management experience)

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

(Technical experience)

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

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