1+ months

Manager, Commissioning & Qualification

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

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Categories

Industry

  • Biotechnology
Posted: 2022-04-08 Expires: 2022-06-08

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Manager, Commissioning & Qualification

Emergent BioSolutions Inc.

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