Senior Engineering Specialist – Drug Substance Manufacturing

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

Senior Engineering Specialist - Drug Substance Manufacturing page is loaded## Senior Engineering Specialist - Drug Substance Manufacturinglocations: Kvistgaardtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR101586**Shape the engineering solutions behind vaccines that protect lives every day**Join Bavarian Nordic and take a leading role in shaping the processes and systems that support our Drug Substance manufacturing.From major capital projects and technology transfers to solving complex manufacturing challenges, you will help ensure our processes are robust, scalable, and ready for reliable operation.**Your impact**As Senior Engineering Specialist, you will serve as a technical authority for integrated bioprocess systems across process engineering, automation, filtration, and equipment design.You will guide critical technical decisions throughout the manufacturing lifecycle - from concept and scale-up through qualification, validation, and continuous improvement.This is a senior individual-contributor role with broad technical responsibility and influence across functions and projects. You will lead technical workstreams and mentor experienced engineers without formal line-management responsibility.**What you will do**Working closely with Manufacturing, Engineering, Automation, Quality, Validation, and external partners, you will:* **Lead bioprocess design and optimization:** Set the technical direction for upstream and downstream processes, purification, bulk formulation, and sterile transfers. Use process knowledge, modelling, and manufacturing data to improve yield, capacity, reliability, and product quality.* **Shape automation and control strategies:** Translate process needs into requirements for PLC/DCS and SCADA systems, recipes, sequences, interlocks, and alarms. Ensure solutions support effective process control, data integrity, and reliable operation.* **Provide technical leadership for filtration:** Define filter selection, sizing, validation, and integrity-testing strategies for liquid and gas systems. Lead investigations into filter failures, pressure deviations, and performance issues.* **Guide equipment and system design:** Review and approve tanks, piping, pumps, valves, and instrumentation, including hydraulic calculations, pressure distribution, and pressure-testing strategies. Lead technical decisions for Cleaning-in-Place and Sterilization-in-Place (CIP/SIP) systems.* **Deliver projects and technology transfers:** Lead process engineering activities from concept and vendor selection through factory and site acceptance testing, commissioning, qualification, process validation, and handover to operations.* **Strengthen technical standards and compliance:** Resolve complex investigations, support change controls and CAPAs, and represent engineering during audits and inspections. Establish reusable design standards and share knowledge across projects and teams.**What you bring**You have a master's degree or PhD in Bioengineering, Biochemical or Chemical Engineering, Biotechnology, Mechanical Engineering, or a closely related discipline.You bring substantial industrial experience, typically 15 years or more, including at least 10 years within pharmaceutical, biotechnology or vaccine manufacturing.Your experience includes:* Leading complex engineering projects as a lead engineer or technical authority, with hands-on expertise in bioprocess development, scale-up, commercial manufacturing, and lifecycle management.* Integrating process equipment with automation and SCADA systems, including control strategies, computerized-system validation, and data integrity.* Designing and validating filtration systems, including filter integrity testing and pressure/flow troubleshooting.* Working with hygienic tanks and piping, hydraulic calculations, pressure testing, CIP/SIP, and contamination control.* Leading commissioning, qualification, process validation, Process Performance Qualification, and technology transfer, supported by a strong understanding of GMP and quality risk management.* Setting technical standards, mentoring experienced engineers, and influencing decisions across functions without relying on formal authority.**How you work**You combine scientific depth with practical engineering judgement. You can move from detailed technical analysis to clear recommendations that help colleagues and leaders make informed decisions.You take ownership, challenge assumptions constructively, and remain focused when problems span multiple systems or disciplines. Whether working with operators, specialists, suppliers, or senior stakeholders, you communicate clearly and build trust through sound decisions and consistent follow-through.You also enjoy developing others. Sharing expertise, coaching colleagues, and creating common standards are natural parts of how you work.At Bavarian Nordic, we work to protect lives through vaccines. In this role, you will help build and improve the manufacturing capabilities that make that purpose possible.You will have the opportunity to influence major technical decisions, strengthen engineering practices, and see your work translate into measurable improvements in manufacturing performance and reliable supply.Our values - Persisting Pioneers, Embracing Change, and Boosted by the Team - shape how we collaborate and solve challenges. For the right candidate, sustained performance may open opportunities for broader engineering leadership or formal people management.We look forward to receiving your application and learning how your technical expertise and leadership could strengthen Bavarian Nordic.We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.*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**#LI-MO1*