Senior Engineering Specialist – Drug Substance Manufacturing

Senior Engineering Specialist
- Drug Substance Manufacturing page is loaded## Senior Engineering Specialist
- Drug Substance Manufacturinglocations: Kvistgaardtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR101586Shape the engineering solutions behind vaccines that protect lives every dayJoin 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 impactAs 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 doWorking 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 bringYou 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 workYou 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 manuf