B

Bavarian Nordic

Develops cancer immunotherapies and vaccines

Biorisk Management Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeKvistgård, DenmarkIn-person

About the Job

Requirements

  • A Bachelor's or Master's degree in engineering, preferably in biochemical, biotechnology, biosafety, process, or mechanical engineering, or a related technical field.
  • Experience in pharmaceutical or biomanufacturing environments, ideally vaccine production or high-containment operations.
  • A strong understanding of biosafety risk assessment, containment strategies, and GMP-aligned engineering.
  • Practical knowledge of bioprocess equipment, cleanrooms, HVAC, HEPA filtration, pressure cascades, decontamination, and waste inactivation.
  • Experience with design reviews, technical risk assessments, facility or equipment changes, and CQV documentation.
  • Ability to turn complex biorisk management requirements into workable solutions and communicate clearly across functions and with external partners.
  • A proactive approach to containment integrity, sound technical judgement, and curiosity.
  • Ability to work independently and collaboratively.
  • Structured and dependable approach to managing priorities and maintaining traceable documentation.
  • Ability to constructively challenge assumptions and drive continuous improvement.

Responsibilities

  • Drive biorisk management from the engineering side, linking biorisk management, facility and process engineering, utilities, security, and operations.
  • Assess facilities, equipment, and processes, and translate risk assessments and regulations into practical engineering controls.
  • Advise on containment strategies, including pressure cascades, HVAC, HEPA filtration, decontamination, and waste inactivation.
  • Define the biorisk management basis of design for new laboratories, production facilities, expansions, and BSL-3 projects.
  • Participate in design reviews and risk assessments, including FMEA, HAZOP, and LOPA, and challenge solutions that could compromise containment.
  • Ensure risk controls are tested, documented, and handed over to operations.
  • Identify containment gaps and improvement opportunities in existing facilities, and support changes while balancing GMP, operability, and business continuity.
  • Contribute engineering expertise to investigations, deviations, CAPAs, audits, and inspections.
  • Build containment awareness across the organization through advice and training.
  • Support risk-based commissioning, qualification, and verification (FAT, SAT, IQ, OQ, and PQ), and define acceptance criteria and test strategies for containment-critical systems.
  • Perform hands-on testing and troubleshooting when needed.
  • Work with Security, IT, and Automation to integrate access control, CCTV, intrusion detection, and zoning with containment systems.

Desired Qualifications

  • Hands-on CQV experience from high-containment facilities, automated CIP/SIP, aseptic processing, building automation, or containment monitoring.
  • Familiarity with FMEA, HAZOP, LOPA, applicable biorisk management legislation, ISO 35001, EU GMP, and WHO biosafety guidance.
  • Knowledge of physical security systems and experience managing cross-functional technical projects.
  • Additional training or certification in commissioning, qualification, validation, HVAC testing, building automation, containment engineering, or security systems.

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

Recently Posted Jobs

Explore more opportunities at Bavarian Nordic

See more jobs