Senior Bioprocess Engineering Specialist

Bavarian Nordic; Rom By; On-site; DKK 1,100,000 - 1,500,000; Full time

Job summary

Bavarian Nordic is seeking a Senior Engineering Specialist to lead bioprocess design and automation initiatives for Drug Substance manufacturing. You will guide upstream/downstream processes, filtration, and sterile transfers while ensuring data integrity and robust GMP practices.

With extensive experience in pharmaceutical manufacturing, you will mentor engineers and drive technology transfers, commissioning, and process validation across projects.

Qualifications

• Master's degree or PhD in Bioengineering, Biochemical or Chemical Engineering, Biotechnology, Mechanical Engineering, or a closely related discipline.
• 15+ years industrial experience in pharmaceutical/biotech or vaccine manufacturing, including 10+ years in related roles.
• Experience leading complex engineering projects as lead engineer or technical authority.
• Experience integrating process equipment with automation and SCADA systems, including validation and data integrity.
• Design and validation of filtration systems, including filter integrity testing and pressure troubleshooting.
• Hands-on in hygienic tanks, piping, hydraulic calculations, pressure testing, CIP/SIP, and contamination control.
• Strong GMP knowledge and quality risk management, with capability to lead audits and change controls.

Responsibilities

• Lead bioprocess design and optimization across upstream/downstream, purification, bulk formulation, and sterile transfers.
• Shape automation and control strategies for PLC/DCS/SCADA, including recipes, interlocks, and alarms.
• Provide technical leadership for filtration, including selection, sizing, validation, and integrity testing.
• Review and approve tanks, piping, pumps, valves, and instrumentation; lead CIP/SIP strategy development.
• Deliver projects and technology transfers from concept to commissioning, validation, and handover to operations.
• Strengthen technical standards, support CAPAs, and represent engineering during audits and inspections.

Skills

Bioprocess development

Scale-up

Process validation

GMP compliance

Automation & SCADA

Filtration design

Education

Master's degree or PhD in Bioengineering/Biochemical/Chemical Engineering or related

Tools

PLC/SCADA integration

CIP/SIP design

Job description

Bavarian Nordic is seeking a Senior Engineering Specialist to lead bioprocess design and automation initiatives for Drug Substance manufacturing. You will guide upstream/downstream processes, filtration, and sterile transfers while ensuring data integrity and robust GMP practices.

With extensive experience in pharmaceutical manufacturing, you will mentor engineers and drive technology transfers, commissioning, and process validation across projects.