DSP Manufacturing Process Expert/Bioprocess Engineer

Contract start date: Immediately

Contract end date: 31 Jan 2027

Location: Visp

Key Responsibilities

Manufacturing Operations

• Plan, coordinate, execute, and document manufacturing campaigns within the assigned DSP production area.
• Ensure manufacturing activities are performed in accordance with cGMP guidelines, approved procedures, and regulatory requirements.
• Support batch execution through process monitoring, evaluation of test results, issue resolution, and troubleshooting of manufacturing equipment and processes.
• Identify and implement corrective and preventive measures to ensure reliable and efficient manufacturing performance.

Product and Process Ownership

• Serve as Functional Lead for all manufacturing aspects of assigned products.
• Lead and coordinate multidisciplinary teams to ensure successful execution of manufacturing campaigns.
• Ensure manufacturing processes, equipment, and facilities remain aligned with current industry standards and regulatory expectations.
• Drive technical expertise and process knowledge within the assigned production area.

Risk Management and Compliance

• Prepare, facilitate, and execute SHE (Safety, Health and Environment), Environmental Monitoring (EM), operational, cleaning, and product-specific risk assessments.
• Ensure implementation, effectiveness, and continuous monitoring of identified mitigation measures.
• Support investigations, deviations, CAPAs, change controls, and risk management activities.
• Ensure compliance with applicable cGMP, EHS, quality, and regulatory requirements.

Documentation and GMP Systems

• Establish, review, and maintain production documentation in a timely and compliant manner.
• Ensure implementation and maintenance of relevant GMP documents, including SOPs, manufacturing instructions, risk assessments, and associated records.
• Support audit readiness through accurate and complete documentation practices.
• Training and Operational Support
• Develop and deliver training programs for production operators and manufacturing personnel related to assigned products and processes.
• Support Plant Managers and Manufacturing Leadership in workforce planning, training coordination, and capability development.
• Promote a culture of operational excellence, quality, safety, and continuous learning.

Capital Projects and Facility Readiness

• Act as manufacturing representative and subject matter expert in capital investment projects.
• Provide production requirements and technical input for facility design, equipment selection, automation concepts, commissioning, qualification, and operational startup.
• Support successful transfer of new technologies, products, and manufacturing processes into routine operations.
• Continuous Improvement and Innovation
• Lead or support innovation, optimization, and continuous improvement initiatives across the manufacturing plant.
• Drive standardisation of processes, equipment, documentation, and manufacturing practices.
• Identify opportunities to improve safety, quality, productivity, robustness, and operational efficiency.
• Customer and Regulatory Interaction
• Represent the manufacturing organisation during customer audits, inspections, and site visits.
• Provide technical expertise and manufacturing support during internal and external audits.
• Act as a professional ambassador for the manufacturing organisation.

Qualifications

• 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.