Biorisk Management Engineer

Bavarian Nordic A/S; Rom By; On-site; DKK 739,000 - 903,000; Full time

Benefits offered by this job

Flexible working conditions

Pension scheme

Health insurance

Competitive compensation and bonus

Job summary

Bavarian Nordic A/S is seeking a Biorisk Management Engineer to bridge biosafety, biosecurity and engineering at our Kvistgård site. You will turn biosafety and biosecurity requirements into practical engineering solutions that are maintainable, verifiable and compliant across facilities, utilities and processes.

The role involves close collaboration with Engineering, Operations, Process Development, Quality, EHS and project teams.

Qualifications

• Bachelor's or Master's in engineering or related technical field.
• Experience in pharmaceutical/biomanufacturing environments, ideally vaccine production or high-containment operations.
• Strong understanding of biosafety risk assessment and GMP-aligned engineering.
• Practical knowledge of bioprocess equipment, cleanrooms, HVAC, HEPA filtration, decontamination, and waste inactivation.
• Experience with design reviews, risk assessments, facility or equipment changes, and CQV documentation.

Responsibilities

• Be the containment expert our projects and operations rely on.
• Drive biorisk management from the engineering side, linking BRM with facility/ process engineering and operations.
• Assess facilities, equipment and processes, turning risk assessments into robust engineering controls.
• Advise on containment strategies: pressure cascades, HVAC, HEPA filtration, decontamination and waste inactivation.
• Join design reviews and risk assessments and challenge solutions impacting containment.
• Ensure risk controls are tested, documented and handed over to operations.

Skills

Biochemical Eng

Biotech/pharma

Biosafety risk assessment

GMP-aligned engineering

Design reviews / risk assessments

Education

Bachelor's or Master's in Engineering

Tools

CQV documentation

Job description

Help us keep containment strong, from the first design sketch to daily operations Vaccines protect people, and protecting the people who make them is just as important. At Bavarian Nordic, we are looking for a Biorisk Management Engineer (BRM) to bridge biosafety, biosecurity, and engineering at our Kvistgaard site. You will make sure containment is built into our facilities, utilities, equipment, and processes. That applies to the buildings we run today and to the expansions and projects that will shape our future.

About the role

You will be the go‑to engineering expert on biorisk management, working closely with Engineering, Operations, Process Development, Quality, EHS, and project teams. Your job is to turn biosafety and biosecurity requirements into engineering solutions that are practical, maintainable, and verifiable.

Your responsibilities

• Be the containment expert our projects and operations rely on
• Drive biorisk management from the engineering side, as the link between BRM, facility and process engineering, utilities, security, and operations
• Assess facilities, equipment, and processes, and turn risk assessments and regulations into robust, practical engineering controls
• Advise on containment strategies, from pressure cascades, HVAC, and HEPA filtration to decontamination and waste inactivation
• Shape the future of our Kvistgaard site
• Define the BRM basis of design for new laboratories, production facilities, expansions, and BSL-3 projects
• Join design reviews and risk assessments (FMEA, HAZOP, LOPA), and challenge solutions that could compromise containment
• Make sure risk controls are tested, documented, and handed over smoothly to operations
• Strengthen what we run today
• Spot containment gaps and improvement opportunities in existing facilities, and support changes while balancing GMP, operability, and business continuity
• Contribute your engineering expertise to investigations, deviations, CAPAs, audits, and inspections
• Build containment awareness across the organization through advice and training
• Get hands‑on with qualification and testing
• Support risk‑based commissioning, qualification, and verification (FAT, SAT, IQ, OQ, PQ) and define acceptance criteria and test strategies for containment‑critical systems
• Step into hands‑on testing and troubleshooting when it matters
• Safeguard both biosafety and biosecurity
• Work with Security, IT, and Automation to integrate access control, CCTV, intrusion detection, and zoning with our containment systems

Who you are

You have

• A Bachelor’s or Master’s degree in engineering, preferably Biochemical, Biotechnology, Biosafety, Process, or Mechanical Engineering, or a related technical field
• Experience from 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
• The ability to turn complex BRM requirements into workable solutions and to communicate clearly across functions and with external partners

It is an advantage if you have

• Hands‑on CQV experience from high‑containment facilities, automated CIP/SIP, aseptic processing, building automation, or containment monitoring
• Familiarity with FMEA, HAZOP, LOPA, applicable BRM 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

You are

• A proactive advocate for containment integrity, with sound technical judgement and genuine curiosity
• Comfortable working both independently and in close collaboration with others
• Structured and dependable, able to manage priorities and keep documentation traceable
• Someone who constructively challenges assumptions and drives continuous improvement

What we offer

A role with real impact on safety, compliance, and the facilities that produce vaccines for people around the world.

A varied mix of strategic development work and hands‑on operational support.

Close collaboration with skilled colleagues across engineering, quality, operations, and projects.

A professional, international environment where your expertise is valued and your development is supported.

Salary Package Annual base salary range: DKK 738.810 –902.990 gross.

Flexible working conditions, pension scheme, health insurance, competitive compensation package and potential bonus opportunities. At Bavarian Nordic, we are committed to fair and transparent pay. The final base salary within this range will be determined based on the candidate’s relevant experience, qualifications, and competencies, as well as internal pay equity.

Bavarian Nordic is an Equal Opportunity Employer

All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

About Bavarian Nordic

Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.

Bavarian Nordic is an Equal Opportunity Employer

All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Contact

For more information, visit www.bavarian-nordic.com