Process Excellence Engineer, Drug Substance Manufacturing

Bavarian Nordic A/S; Denmark; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Bavarian Nordic A/S is seeking an Engineering Specialist to strengthen Drug Substance manufacturing processes and support the introduction of new equipment and technologies. You will join the Material & Sterile Operation team in Denmark, combining hands-on problem solving with technical leadership to ensure reliable performance, quality, and GMP compliance.

You will develop and maintain processes through their lifecycle, lead CIP/SIP design improvements, guide equipment introductions,

Qualifications

• Master’s degree in Chemical, Bioprocess, Process or Mechanical Engineering with 10+ years’ industrial experience.
• Proven track record in process design, optimization and structured troubleshooting in GMP manufacturing.
• Experience in pharmaceuticals/biotech/vaccines or other highly regulated industries preferred.
• Extensive hands-on CIP/SIP design, operation and optimization.
• In-depth knowledge of process equipment, piping, valves, and instrumentation, and integration with automation systems.
• Experience with equipment introduction, qualification, validation, PPQ and technology transfer.

Responsibilities

• Lead process design and optimization to improve efficiency, reliability, and quality.
• Act as Subject Matter Expert for CIP/SIP systems; improve design and cleaning strategies.
• Guide equipment introduction from specifications through factory acceptance, commissioning, qualification, and validation.
• Develop validation strategies; lead PPQ and tech transfer.
• Lead deviations, root cause investigations, 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 knowledge

Regulatory awareness

Education

Master's degree in Chemical, Bioprocess, Process, or Mechanical Engineering

Tools

Equipment qualification

PPQ (Process Performance Qualification)

Job description

Bavarian Nordic A/S is seeking an Engineering Specialist to strengthen Drug Substance manufacturing processes and support the introduction of new equipment and technologies. You will join the Material & Sterile Operation team in Denmark, combining hands-on problem solving with technical leadership to ensure reliable performance, quality, and GMP compliance.

You will develop and maintain processes through their lifecycle, lead CIP/SIP design improvements, guide equipment introductions,