Manufacturing Process Expert – DSP (7055)

Manufacturing Process Expert (DSP) – 7055 URA

 

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a: Manufacturing Process Expert for a 6 months contract role to be working onsite from, Visp, Valais area, Switzerland.

The Process Engineer is responsible for the technical planning, execution, monitoring, and continuous improvement of commercial and clinical manufacturing operations within the Downstream Processing (DSP) area. Acting as the manufacturing Subject Matter Expert (SME) for assigned products, the role ensures safe, compliant, and efficient production in accordance with current Good Manufacturing Practice (cGMP), regulatory requirements, and operational excellence principles.

Working closely with Manufacturing, Quality, Engineering, MSAT, Validation, Supply Chain, and Project teams, the DSP Bioprocess Engineer provides technical leadership for manufacturing campaigns, supports troubleshooting and investigations, drives process optimization, and contributes 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 in accordance with cGMP and regulatory requirements.

·      Serve as the manufacturing Subject Matter Expert (SME) and Functional Lead for assigned products, providing technical leadership and supporting 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 driving root cause investigations.

·      Lead quality and compliance activities, including deviations, CAPAs, change controls, risk assessments, validation support, and implementation of corrective and preventive actions.

·      Develop, review, and maintain GMP documentation, including SOPs, batch records, manufacturing instructions, risk assessments, and technical reports to ensure inspection readiness.

·      Drive continuous improvement initiatives to optimize manufacturing processes, increase productivity, improve process robustness, enhance product quality, 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, fostering operational excellence, technical capability, 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 reliable, 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 preferred.

·      Strong knowledge of biopharmaceutical manufacturing and downstream processing operations.

·      Sound understanding of cGMP regulations and regulatory expectations.

·      Experience in risk management, deviation handling, CAPA, change control, and validation activities.

·      Strong technical troubleshooting and problem-solving skills.

·      Excellent communication and stakeholder management abilities.

·      Project leadership and cross-functional collaboration skills.

·      Ability to work effectively in a dynamic and highly regulated manufacturing environment.