Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of over $45 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
At our Lengnau, Switzerland site, our state-of-the-art, multi-purpose facility supports the large-scale production of biologics and offers significant potential for future expansion.
We are looking for an experienced Senior Manufacturing Engineer to provide technical leadership and operational support within our Drug Substance Manufacturing organization.
As Senior Manufacturing Engineer, you will play a key role in ensuring our biologics manufacturing processes are robust, reliable, compliant and operationally ready.
Working closely with Manufacturing, Engineering, Automation, Quality, Maintenance and other technical functions, you will act as a technical subject matter expert supporting both routine manufacturing and the continued development of our production capabilities.
You will provide expertise across Upstream Processing (USP), Downstream Processing (DSP) and/or supporting processes e.g buffer and media preparation, troubleshooting complex manufacturing challenges and driving sustainable technical solutions.
You will also support Technology Transfer, New Product Introduction (NPI), commissioning, qualification, validation and operational readiness for new products, equipment and production capabilities.
This is a hands-on technical role for someone who enjoys working close to the manufacturing process and translating engineering and scientific knowledge into reliable shop-floor execution.
-
Act as a technical subject matter expert and first point of contact for Manufacturing within your assigned process area.
-
Provide technical support for biologics Drug Substance manufacturing across USP, DSP and associated support processes.
-
Troubleshoot complex process and equipment issues and lead the development of sustainable solutions.
-
Support the definition and optimization of robust process parameters during manufacturing campaigns.
-
Provide technical guidance, coaching and training to Manufacturing colleagues.
-
Develop a strong understanding of manufacturing equipment, process capabilities and operating limitations.
-
Support equipment preparation, cleaning, Clean-in-Place (CIP) and Steam-in-Place (SIP) processes.
-
Understand the interaction between process design, equipment, automation and recipe configuration, and identify technical constraints that can impact manufacturing execution.
-
Work closely with Engineering, Automation and Maintenance to resolve equipment, automation and process-related challenges.
-
Identify opportunities to improve process robustness, equipment reliability and operational performance.
-
Design and update of automation recipe related documentation.
-
Lead and provide technical expertise for manufacturing deviations, process excursions and equipment-related investigations.
-
Apply structured problem-solving and root-cause analysis to identify underlying causes.
-
Define and support effective Corrective and Preventive Actions (CAPAs).
-
Use manufacturing data, deviations and operational experience to identify recurring issues and improvement opportunities.
-
Lead and contribute to Manufacturing Excellence and Practical Process Improvement (PPI) initiatives.
-
Support Technology Transfer and New Product Introduction activities.
-
Lead operational readiness activities within your area of expertise.
-
Support commissioning, qualification, Performance Qualification (PQ) and Process Validation activities.
-
Ensure Manufacturing requirements and operational experience are incorporated into equipment and process design.
-
Support the successful start-up and transition of new products, equipment and production capabilities into routine GMP manufacturing.
-
Own and maintain SOPs, Work Instructions and technical GMP documentation within your area.
-
Own and drive change controls, deviations, investigations and CAPAs to completion.
-
Ensure technical solutions and process changes are appropriately assessed and documented.
-
Work in accordance with applicable cGMP, Quality and EHSS requirements.
-
Bachelor's or Master's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, Chemistry, or another relevant scientific or engineering discipline.
-
Strong professional experience in pharmaceutical or biopharmaceutical manufacturing within a GMP environment.
-
Practical knowledge of biologics Drug Substance manufacturing, ideally within USP and/or DSP and/or Media and buffer preparations.
-
Experience with CIP and SIP processes, equipment preparation, cleaning and sterilization.
-
Strong process and equipment troubleshooting capabilities.
-
Experience with deviations, root-cause investigations, CAPAs and change controls.
-
Experience with Technology Transfer, NPI, commissioning, qualification and/or Process Validation.
-
Understanding of how equipment, automation systems, recipe design and process requirements interact and can create constraints within manufacturing.
-
Ability to analyze manufacturing data and translate technical findings into practical solutions.
-
Strong cross-functional communication and stakeholder-management skills.
-
Professional proficiency in English; German is an advantage.
-
Availability to provide on-call support when required.
You enjoy being close to manufacturing operations and are comfortable moving between the shop floor and detailed technical problem-solving.
You understand the relationship between process, equipment, automation and people, and you can identify how technical limitations or dependencies affect successful manufacturing execution.
You are curious and analytical. When something does not perform as expected, you want to understand why and develop a solution that prevents the issue from recurring.
Resilience, adaptability and composure are key to success in this role. Manufacturing is a dynamic and demanding environment where priorities can change quickly and complex technical challenges may require persistence to resolve. You remain calm and patient under pressure, communicate clearly and take a structured approach even when timelines are tight or the solution is not immediately obvious.
Just as importantly, you are pragmatic and able to simplify complexity. You focus on what is important, avoid unnecessary complexity and translate technical challenges into clear, practical and executable solutions. You know when detailed analysis is required and when a straightforward solution is the right one.
As our manufacturing processes and operating model continue to mature, you are comfortable working through evolving processes and new technical challenges, balancing technical rigor with practicality and a strong sense of urgency.
As a senior technical member of the team, you take ownership, share your knowledge and help develop the technical capabilities of those around you.
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.
Join our team in Lengnau and bring your technical expertise to an environment where you can directly influence the reliability, robustness and future development of our biologics manufacturing operations.
