Manufacturing Process Expert / Manufacturing Process Expertess

Manufacturing Process Expert (DSP) – 7055 URA

Our client, a global leader in the production and process support of active pharmaceutical ingredients across both chemical and biotechnology sectors, is seeking a Manufacturing Process Expert for a 6-month onsite contract role in the Visp, Valais area of Switzerland.

The Process Engineer will be responsible for the technical planning, execution, monitoring, and continuous improvement of commercial and clinical manufacturing operations within the Downstream Processing (DSP) area. As the manufacturing Subject Matter Expert (SME) for assigned products, this role will ensure safe, compliant, and efficient production aligned with current Good Manufacturing Practices (cGMP), regulatory requirements, and operational excellence principles.

By collaborating closely with Manufacturing, Quality, Engineering, MSAT, Validation, Supply Chain, and Project teams, the DSP Bioprocess Engineer will provide technical leadership for manufacturing campaigns, assist with troubleshooting and investigations, drive process optimization, and contribute to the successful implementation of new technologies and capital projects.

Main Responsibilities:

• Plan, coordinate, execute, and monitor commercial and clinical downstream manufacturing campaigns, ensuring safe, efficient, and compliant production according to cGMP and regulatory standards.
• Serve as the manufacturing Subject Matter Expert (SME) and Functional Lead for assigned products, offering technical leadership and support to cross-functional teams throughout the product lifecycle.
• Provide real-time manufacturing support by monitoring process performance, troubleshooting equipment and process issues, resolving technical challenges, and conducting root cause investigations.
• Lead quality and compliance activities, including deviations, CAPAs, change controls, risk assessments, validation support, and implementing corrective and preventive actions.
• Develop, review, and maintain GMP documentation such as SOPs, batch records, manufacturing instructions, risk assessments, and technical reports to ensure inspection readiness.
• Drive continuous improvement initiatives to optimize manufacturing processes, enhance productivity, improve process robustness, and standardize manufacturing practices.
• Support capital projects, technology transfers, and operational readiness by providing manufacturing expertise for facility design, equipment selection, commissioning, qualification, and implementation of new processes.
• Develop and deliver technical training to manufacturing personnel, promoting operational excellence and a strong culture of quality, safety, and compliance.
• Represent the Manufacturing organization during customer audits, regulatory inspections, and cross-functional projects by providing technical expertise and ensuring manufacturing readiness.
• Collaborate with Engineering, Quality, MSAT, Validation, Supply Chain, and Manufacturing teams to achieve operational objectives, support strategic initiatives, and ensure dependable, efficient, and compliant manufacturing operations.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU citizenship required.
• Bachelor's or Master's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or a related discipline.
• Relevant experience in biopharmaceutical manufacturing, downstream processing, process engineering, or technical operations.
• Experience working in a cGMP-regulated environment is preferred.
• Strong understanding of biopharmaceutical manufacturing and downstream processing operations.
• Sound knowledge of cGMP regulations and regulatory expectations.
• Experience with risk management, deviation handling, CAPA, change control, and validation activities.
• Strong technical troubleshooting and problem-solving abilities.
• Excellent communication and stakeholder management skills.
• Proficient in project leadership and cross-functional collaboration.
• Ability to perform effectively in a dynamic and highly regulated manufacturing environment.

Apply online using the form below. Please note that only applications matching the job profile will be considered.