Engineering Specialist – Drug Substance Manufacturing

Bavarian Nordic Berna GmbH; Denmark; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Bavarian Nordic Berna GmbH in Denmark is seeking an Engineering Specialist to strengthen Drug Substance manufacturing processes and support the introduction of new equipment and technologies.

You will join Material & Sterile Operation, combining hands-on problem-solving with technical leadership to ensure GMP-compliant, reliable production. A master’s degree and 10+ years' industry experience are expected.

Qualifications

• Master's degree in Chemical, Bioprocess, Process, or Mechanical Engineering or related field.
• 10+ years of industrial process engineering experience.
• Strong GMP manufacturing experience in pharmaceuticals/biotech.
• Extensive hands-on CIP/SIP design experience.
• In-depth knowledge of process equipment, piping, valves, and instrumentation.
• Experience with equipment introduction, qualification, validation, PPQ, and technology transfer (including regulatory aspects).
• Solid knowledge of pharmaceutical quality systems and regulatory expectations.

Responsibilities

• Lead process design and optimization to improve efficiency, reliability, and quality.
• Act as SME for CIP/SIP systems, improving design and cleaning strategies.
• Guide equipment introduction through specifications, design reviews, testing, and validation.
• Develop validation strategies and lead PPQ and tech transfer efforts.
• Lead deviations, root causes, CAPAs, change controls, and risk assessments; support audits.
• Coach colleagues and share engineering knowledge to strengthen process understanding.

Skills

Process design

Process optimization

Troubleshooting

CIP/SIP design

Equipment intro

Validation

Technology transfer

CAPA

Audit support

Leadership

Coaching

Education

Master's degree in Chemical/ Bioprocess/ Process/ Mechanical Eng

Tools

Process equipment

Job description

Bring your engineering expertise to processes that help protect lives every day

Do you enjoy solving complex manufacturing challenges and turning technical insight into lasting improvements?

At Bavarian Nordic, we are looking for a Engineering Specialist to strengthen our Drug Substance manufacturing processes and support the introduction of new equipment and technologies.

You will join Material & Sterile Operation, reporting to the Senior Manager, and combine hands‑on problem‑solving with technical leadership. Your work will help ensure that our processes deliver reliable performance, consistent quality, and GMP compliance.

Your impact

As a technical expert for your assigned process areas, you will help develop, optimize, validate, and maintain manufacturing processes throughout their lifecycle. You will challenge existing solutions, identify risks before they affect production, and turn improvement opportunities into practical results.

Working across Manufacturing, Engineering, Automation, and Quality, you will also share your expertise and strengthen process understanding across teams.

What you will do

• Improve process performance: Lead process design and optimization, address bottlenecks and operational risks, and troubleshoot complex manufacturing challenges to improve efficiency, reliability, and quality.
• Provide expertise in CIP/SIP: Act as a Subject Matter Expert for Cleaning-in-Place and Sterilization-in-Place systems, improving system design, component selection, and cleaning and sterilization strategies.
• Introduce equipment and technologies: Guide technical activities from specifications and vendor design reviews through factory and site acceptance testing, commissioning, qualification, and validation.
• Support validation and technology transfer: Develop validation strategies, lead and support Process Performance Qualification (PPQ), and drive the transfer of processes into manufacturing or between sites.
• Strengthen compliance: Lead and support deviations, root cause investigations, CAPAs, change controls, and risk assessments. Represent your technical areas during audits and inspections.
• Develop technical capability: Coach colleagues, provide training, and share engineering knowledge to strengthen process understanding and consistent execution.

What you bring

You hold a master’s degree in Chemical, Bioprocess, Process, or Mechanical Engineering, or a related engineering discipline, and have at least 10 years of industrial process engineering experience.

• A strong track record in process design, optimization, and structured troubleshooting within GMP manufacturing. Experience in pharmaceuticals, biotechnology, vaccines, or another highly regulated industry is strongly preferred.
• Extensive hands‑on expertise in CIP/SIP design, operation, and optimization.
• In‑depth knowledge of process equipment, piping, valves, and instrumentation, together with an understanding of how process and automation systems interact.
• Experience with equipment introduction, qualification, validation, PPQ, and technology transfer, including changes requiring regulatory approval.
• Solid knowledge of pharmaceutical quality systems and regulatory expectations, with practical experience in investigations, CAPAs, change controls, risk assessments, and inspection support.

How you work

You combine analytical thinking with practical judgement and take ownership of moving issues towards resolution.

You are comfortable questioning established practices and can explain why a proposed change will improve process performance or reduce risk.

You communicate complex technical topics clearly, build constructive relationships across functions, and balance attention to detail with an understanding of production needs and business priorities. You also enjoy helping others develop through coaching, knowledge sharing, and collaboration.

An opportunity to grow your leadership

This role offers the opportunity to make an immediate impact through technical leadership. For the right candidate, it may also provide a pathway into formal people management, potentially leading a team of approximately 8–10 Process Engineers.

Progression will depend on demonstrated performance, sound judgement, and the ability to develop others, build an inclusive team environment, and translate business priorities into practical execution.

Why join Bavarian Nordic?

At Bavarian Nordic, we work to protect lives through vaccines. Your engineering expertise will contribute directly to the manufacturing processes that make this possible.

You will have opportunities to influence technical solutions, support important technology transfers, and see your improvements become part of daily operations. Guided by our values—Persisting Pioneers, Embracing Change, and Boosted by the Team—we work together to solve challenges and strengthen our capabilities

Company profile

Improving and saving lives through innovative vaccines is at the heart of what we do at Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing and commercialisation of life‑saving vaccines, and the largest pure‑play vaccine company in the world.

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