Biorisk Management Engineer

Bavarian Nordic; Kvistgård; Presencial; DKK 739.000 - 903.000; Tempo integral

Benefícios oferecidos por esta vaga

Health insurance

Pension scheme

Bonus opportunities

Resumo da vaga

Bavarian Nordic is seeking a Biorisk Management Engineer to bridge biosafety, biosecurity and engineering at our Kvistgård site. You will translate biosafety requirements into practical, verifiable engineering controls across facilities, utilities, and processes.

You will lead BRM in design reviews, risk assessments, and commissioning activities, collaborating with Engineering, Operations, Quality and Project teams to safeguard containment and GMP compliance.

Qualificações

• You have a degree in engineering or related field and experience in pharma or biomanufacturing.
• You understand biosafety risk assessment and containment strategies in GMP settings.
• You can translate BRM requirements into practical, verifiable engineering controls.

Responsabilidades

• Be the containment expert for projects and operations, bridging BRM with engineering and facilities.
• Assess facilities, equipment, and processes; convert risk assessments into robust controls.
• Advise on containment strategies including HVAC, pressure cascades, HEPA filtration, and decontamination.
• Define BRM basis of design for labs, production facilities, and BSL-3 projects.
• Join design reviews and risk assessments; challenge solutions that affect containment.
• Ensure risk controls are tested, documented, and handed over to operations.
• Support risk-based commissioning, qualification, and verification (FAT, SAT, IQ, OQ, PQ).
• Collaborate with Security, IT, and Automation to integrate access control and zoning.

Conhecimentos

Biorisk management

Engineering

Risk assessment

GMP knowledge

FMEA/HAZOP/LOPA

CQV documentation

Cross-functional collaboration

Clear communication

Formação

Bachelor’s or Master’s in engineering

Biochemical/Biotechnology/Biosafety/Process/Mechanical engineering

Ferramentas

HVAC systems

Bio-containment equipment

Descrição da vaga

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 othersStructured 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 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.

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