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

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.