Sr. Manufacturing Engineer

ph3Work Schedule /h3pStandard (Mon-Fri) /ph3Environmental Conditions /h3pAdherence 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.) /ph3Job Description /h3pThermo 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. /ppAt our bLengnau, Switzerland /b site, our state-of-the-art, multi-purpose facility supports the large-scale production of biologics and offers significant potential for future expansion. /ppWe are looking for an experienced bSenior Manufacturing Engineer /b to provide technical leadership and operational support within our Drug Substance Manufacturing organization. /ph3How You Will Make an Impact /h3pAs Senior Manufacturing Engineer, you will play a key role in ensuring our biologics manufacturing processes are robust, reliable, compliant and operationally ready. /ppWorking 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. /ppYou 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. /ppYou will also support Technology Transfer, New Product Introduction (NPI), commissioning, qualification, validation and operational readiness for new products, equipment and production capabilities. /ppThis 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. /ph3What You Will Do /h3h3Manufacturing Technical Support /h3ulliAct as a technical subject matter expert and first point of contact for Manufacturing within your assigned process area. /liliProvide technical support for biologics Drug Substance manufacturing across USP, DSP and associated support processes. /liliTroubleshoot complex process and equipment issues and lead the development of sustainable solutions. /liliSupport the definition and optimization of robust process parameters during manufacturing campaigns. /liliProvide technical guidance, coaching and training to Manufacturing colleagues. /li /ulh3Process, Equipment Automation /h3ulliDevelop a strong understanding of manufacturing equipment, process capabilities and operating limitations. /liliSupport equipment preparation, cleaning, Clean-in-Place (CIP) and Steam-in-Place (SIP) processes. /liliUnderstand the interaction between process design, equipment, automation and recipe configuration, and identify technical constraints that can impact manufacturing execution. /liliWork closely with Engineering, Automation and Maintenance to resolve equipment, automation and process-related challenges. /liliIdentify opportunities to improve process robustness, equipment reliability and operational performance. /liliDesign and update of automation recipe related documentation. /li /ulh3Investigations Continuous Improvement /h3ulliLead and provide technical expertise for manufacturing deviations, process excursions and equipment-related investigations. /liliApply structured problem-solving and root-cause analysis to identify underlying causes. /liliDefine and support effective Corrective and Preventive Actions (CAPAs). /liliUse manufacturing data, deviations and operational experience to identify recurring issues and improvement opportunities. /liliLead and contribute to Manufacturing Excellence and Practical Process Improvement (PPI) initiatives. /li /ulh3Technology Transfer, Qualification Validation /h3ulliSupport Technology Transfer and New Product Introduction activities. /liliLead operational readiness activities within your area of expertise. /liliSupport commissioning, qualification, Performance Qualification (PQ) and Process Validation activities. /liliEnsure Manufacturing requirements and operational experience are incorporated into equipment and process design. /liliSupport the successful start-up and transition of new products, equipment and production capabilities into routine GMP manufacturing. /li /ulh3GMP Documentation Compliance /h3ulliOwn and maintain SOPs, Work Instructions and technical GMP documentation within your area. /liliOwn and drive change controls, deviations, investigations and CAPAs to completion. /liliEnsure technical solutions and process changes are appropriately assessed and documented. /liliWork in accordance with applicable cGMP, Quality and EHSS requirements. /li /ulh3What You Bring /h3h3Education /h3ulliBachelor's or Master's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, Chemistry, or another relevant scientific or engineering discipline. /li /ulh3Experience Skills /h3ulliStrong professional experience in pharmaceutical or biopharmaceutical manufacturing within a GMP environment. /liliPractical knowledge of biologics Drug Substance manufacturing, ideally within USP and/or DSP and/or Media and buffer preparations. /liliExperience with CIP and SIP processes, equipment preparation, cleaning and sterilization. /liliStrong process and equipment troubleshooting capabilities. /liliExperience with deviations, root-cause investigations, CAPAs and change controls. /liliExperience with Technology Transfer, NPI, commissioning, qualification and/or Process Validation. /liliUnderstanding of how equipment, automation systems, recipe design and process requirements interact and can create constraints within manufacturing. /liliAbility to analyze manufacturing data and translate technical findings into practical solutions. /liliStrong cross-functional communication and stakeholder-management skills. /liliProfessional proficiency in English; German is an advantage. /liliAvailability to provide on-call support when required. /li /ulh3What Will Make You Successful /h3pYou enjoy being close to manufacturing operations and are comfortable moving between the shop floor and detailed technical problem-solving. /ppYou understand the relationship between process, equipment, automation and people, and you can identify how technical limitations or dependencies affect successful manufacturing execution. /ppYou 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. /ppResilience, 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. /ppJust 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. /ppAs 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. /ppAs a senior technical member of the team, you take ownership, share your knowledge and help develop the technical capabilities of those around you. /ph3Our Mission Is Our Purpose /h3pAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. /ppJoin 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. /ppThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p /p #J-18808-Ljbffr