Engineering Specialist – Drug Substance Manufacturing

Bavarian Nordic; Rom By; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Bavarian Nordic is seeking an Engineering Specialist to strengthen our Drug Substance manufacturing processes in Denmark. The role combines hands-on problem solving with technical leadership to ensure reliable performance, quality, and GMP compliance.

You will lead process design and optimization, oversee CIP/SIP strategies, support equipment introduction and validation, and contribute to technology transfer and investigations.

Qualifications

• Master's degree in Chemical, Bioprocess, Process, or Mechanical Engineering or related field.
• At least 10 years of industrial process engineering experience in GMP/pharma/biotech settings.

Responsibilities

• Lead process design and optimization to improve efficiency, reliability and quality.
• Act as SME for CIP/SIP design, operation and optimization.
• Guide equipment introduction, vendor reviews, qualification, validation and site acceptance testing.
• Support validation strategies, PPQ and technology transfer between sites.
• Lead deviations, root cause investigations, CAPAs, change controls, and risk assessments; support audits and inspections.
• Coach colleagues and share engineering knowledge to strengthen process understanding across teams.

Skills

Process design

CIP/SIP expertise

Equipment qualification

PPQ & tech transfer

Investigations & CAPAs

Risk assessments

Coaching & knowledge share

Education

Master's degree in Chemical/ Bioprocess/ Process/ Mechanical Eng

Tools

CIP/SIP systems

Process equipment & instrumentation

Job description

Engineering Specialist - Drug Substance Manufacturing page is loaded## Engineering Specialist - Drug Substance Manufacturinglocations: Kvistgaardtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR101588**Bring your engineering expertise to processes that help protect lives every day**At Bavarian Nordic, we are looking for a Engineering Specialist to strengthen our Drug Substance manufacturing processes and support the introduction of new equipment and technologies.You will join Material & Sterile Operation, reporting to the Senior Manager, and combine hands-on problem-solving with technical leadership. Your work will help ensure that our processes deliver reliable performance, consistent quality, and GMP compliance.**Your impact**As a technical expert for your assigned process areas, you will help develop, optimize, validate, and maintain manufacturing processes throughout their lifecycle. You will challenge existing solutions, identify risks before they affect production, and turn improvement opportunities into practical results.Working across Manufacturing, Engineering, Automation, and Quality, you will also share your expertise and strengthen process understanding across teams.**What you will do*** **Improve process performance:** Lead process design and optimization, address bottlenecks and operational risks, and troubleshoot complex manufacturing challenges to improve efficiency, reliability, and quality.* **Provide expertise in CIP/SIP:** Act as a Subject Matter Expert for Cleaning-in-Place and Sterilization-in-Place systems, improving system design, component selection, and cleaning and sterilization strategies.* **Introduce equipment and technologies:** Guide technical activities from specifications and vendor design reviews through factory and site acceptance testing, commissioning, qualification, and validation.* **Support validation and technology transfer:** Develop validation strategies, lead and support Process Performance Qualification (PPQ), and drive the transfer of processes into manufacturing or between sites.* **Strengthen compliance:** Lead and support deviations, root cause investigations, CAPAs, change controls, and risk assessments. Represent your technical areas during audits and inspections.* **Develop technical capability:** Coach colleagues, provide training, and share engineering knowledge to strengthen process understanding and consistent execution.**What you bring**You hold a master's degree in Chemical, Bioprocess, Process, or Mechanical Engineering, or a related engineering discipline, and have at least 10 years of industrial process engineering experience.You bring:* A strong track record in process design, optimization, and structured troubleshooting within GMP manufacturing. Experience in pharmaceuticals, biotechnology, vaccines, or another highly regulated industry is strongly preferred.* Extensive hands-on expertise in CIP/SIP design, operation, and optimization.* In-depth knowledge of process equipment, piping, valves, and instrumentation, together with an understanding of how process and automation systems interact.* Experience with equipment introduction, qualification, validation, PPQ, and technology transfer, including changes requiring regulatory approval.* Solid knowledge of pharmaceutical quality systems and regulatory expectations, with practical experience in investigations, CAPAs, change controls, risk assessments, and inspection support.**How you work**You combine analytical thinking with practical judgement and take ownership of moving issues towards resolution.You are comfortable questioning established practices and can explain why a proposed change will improve process performance or reduce risk.You communicate complex technical topics clearly, build constructive relationships across functions, and balance attention to detail with an understanding of production needs and business priorities. You also enjoy helping others develop through coaching, knowledge sharing, and collaboration.**An opportunity to grow your leadership**This role offers the opportunity to make an immediate impact through technical leadership. For the right candidate, it may also provide a pathway into formal people management, potentially leading a team of approximately 8-10 Process Engineers.Progression will depend on demonstrated performance, sound judgement, and the ability to develop others, build an inclusive team environment, and translate business priorities into practical execution.At Bavarian Nordic, we work to protect lives through vaccines. Your engineering expertise will contribute directly to the manufacturing processes that make this possible.You will have opportunities to influence technical solutions, support important technology transfers, and see your improvements become part of daily operations. Guided by our values - Persisting Pioneers, Embracing Change, and Boosted by the Team - we work together to solve challenges and strengthen our capabilitiesApply by clicking the 'APPLY' button. We are interviewing on an ongoing basis and look forward to receiving your CV.We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.**For us, it is all about improving and saving lives**Improving and saving lives through innovative vaccines is at the heart of what we do at Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing and commercialisation of life-saving vaccines, and the largest pure-play vaccine company in the world.*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*