Senior Commissioning Engineer

☞ Bavarian Nordic

View: 182

Update day: 22-04-2024

Location: Mendrisio Ticino TI

Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software

Industry: Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

Senior Engineer Commissioning & Qualification (f/m/d)

For us, it is all about improving and saving lives

In Bavarian Nordic, we believe in the power of the team. You will be part of a global company of +1,300 dedicated people with diverse backgrounds located in Denmark, Germany, Switzerland, and the USA. We believe in creating an inclusive and flexible workplace with a strong focus on personal and professional development.

For our Bern site, we are looking to strengthen the Engineering (CQV Team) with a Senior Engineer for Commissioning & Qualification. Besides manufacturing activities, we have professionals in Quality Assurance, Quality Control, Supply Chain, and Regulatory affairs counting approx. 140 dedicated and committed professionals working locally and globally.

Main responsibilities:

  • Planning, coordination, and execution of all phases for commissioning and qualification of GMP manufacturing systems according to local and global procedures and standards as well as legal requirements
  • Facilitating the development, performing reviews, and approving technical and GMP-related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
  • Development of C&Q verification documents including but not limited to Commissioning/ Qualification plans, FMEA, IQ, and OQ as well as for the execution of verification activities
  • Coordination and oversight of vendor FAT/SAT, commissioning activities in collaboration with internal and external partners
  • Planning and execution of qualification activities regarding production equipment, QC, and infrastructure
  • Assessing and handling Change Controls, CAPAs, and Non-Conformances related to qualification topics
Our requirements:

  • Bachelor/Master’s degree in Engineering discipline (chemical or mechanical engineering)
  • Proven work experience(3-5 years) in a biotech or pharma company in a cGxP environment and/or C&Q equivalent position
  • Solid written and spoken skills in English, and German is a plus.
  • Experience and knowledge in sterilization cycle development, smoke study, technical air measurement, cleaning validation, and temperature/humidity mapping
  • Know-how of Commissioning and Qualification requirements according to cGMP regulations
  • Excellent knowledge and experience in Downstream processing (DSP)
  • Analytical thinking and problem-solving ability; strong attitude on working collaboratively with all stakeholders to ensure that activities are planned and delivered in the most efficient timeframe
  • Excellent team player with self-management skills
Contact

Please contact Daniel Mauron - Director of HR in Bern at +41 318 885 225, if you have any questions about the role or the organization. We are interviewing on an ongoing basis and look forward to receiving your application as soon as possible. We cannot wait to get to know you better!

Founded in 1994, we have more than 25 years of experience in developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies and tick-borne encephalitis and an Ebola vaccine. We are a global company headquartered in Denmark with a state-of-the-art production facility and sites in Germany, Switzerland, and USA. Our values – our Bavarian Nordic DNA, as we like to call it – is what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer.

www.bavarian-nordic.com
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Deadline: 06-06-2024

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