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Bavarian Nordic

Develops cancer immunotherapies and vaccines

Engineering Specialist - Drug Substance Manufacturing

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeKvistgård, DenmarkNo salary listedIn-person

About the Job

Requirements

  • Hold a master's degree in Chemical, Bioprocess, Process, or Mechanical Engineering, or a related engineering discipline.
  • Have at least 10 years of industrial process engineering experience.
  • Have a strong track record in process design, optimization, and structured troubleshooting within GMP manufacturing.
  • Have extensive hands-on expertise in Cleaning-in-Place and Sterilization-in-Place system design, operation, and optimization.
  • Have in-depth knowledge of process equipment, piping, valves, and instrumentation, and understand how process and automation systems interact.
  • Have experience with equipment introduction, qualification, validation, Process Performance Qualification, and technology transfer, including changes requiring regulatory approval.
  • Have solid knowledge of pharmaceutical quality systems and regulatory expectations, with practical experience in investigations, Corrective and Preventive Actions, change controls, risk assessments, and inspection support.
  • Be able to explain how proposed changes improve process performance or reduce risk, communicate complex technical topics clearly, build constructive cross-functional relationships, and balance attention to detail with production needs and business priorities.

Responsibilities

  • Lead process design and optimization, address bottlenecks and operational risks, and troubleshoot complex manufacturing challenges to improve efficiency, reliability, and quality.
  • Serve as a subject matter expert for Cleaning-in-Place and Sterilization-in-Place systems, improving system design, component selection, and cleaning and sterilization strategies.
  • Guide technical activities for new equipment and technologies from specifications and vendor design reviews through factory and site acceptance testing, commissioning, qualification, and validation.
  • Develop validation strategies, lead and support Process Performance Qualification, and drive process transfers into manufacturing or between sites.
  • Lead and support deviations, root cause investigations, Corrective and Preventive Actions, change controls, and risk assessments; represent technical areas during audits and inspections.
  • Coach colleagues, provide training, and share engineering knowledge to strengthen process understanding and consistent execution.
  • Work across Manufacturing, Engineering, Automation, and Quality to share expertise and strengthen process understanding across teams.

Desired Qualifications

  • Experience in pharmaceuticals, biotechnology, vaccines, or another highly regulated industry is strongly preferred.

About the Company

Bavarian Nordic

Develops cancer immunotherapies and vaccines

Bavarian Nordic develops, manufactures, and sells vaccines and cancer immunotherapies. Its vaccines and immunotherapies aim to train the body's immune system to recognize and attack cancer cells or infectious agents. The company operates as a fully integrated biotechnology business, handling development, production, and commercialization, and it collaborates with partners and licensing agreements to bring its products to market. A key differentiator is its track record, including European marketing authorization for an Ebola vaccine and a licensing deal for a COVID-19 vaccine, plus ongoing partnerships. The company's goal is to improve global health by reducing the risk of infectious diseases and by improving cancer treatment outcomes.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Gentofte Municipality, Denmark
Founded
1994

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