Job Description Job Title: Senior Process Expert – Fill & Finish / Isolator Technical Writing Company: Inova (www.inova-sa.ch) Location: Basel Area, Switzerland Contract Type: Full-time – On-site Start Date: ASAP About Inova: Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high-value expertise in quality, compliance, and digital transformation. We help our clients build robust, future-proof quality systems, from shopfloor execution to enterprise-level governance. Position Overview: We are seeking a Senior Process Expert – Fill & Finish to support a pharmaceutical client in the Basel area, with a strong focus on technical writing and operational documentation for aseptic manufacturing activities. This role is particularly focused on isolator-based operations and will involve the creation, review, and improvement of GMP documentation such as SOPs, Work Instructions, training materials, and process-related documentation for activities including compounding, smoke studies, media fills, PQ phases, and routine fill & finish operations. The ideal candidate combines deep hands-on process expertise with the flexibility and precision required to write clear, compliant, and operationally relevant documentation for manufacturing teams. Key Responsibilities: Write, review, and update GMP documentation related to fill & finish and aseptic processing activities Develop SOPs, Work Instructions, training materials, and operational guidance documents Support documentation for compounding, isolator operations, smoke studies, media fills, and PQ phases Translate hands-on process knowledge into clear, practical, and compliant procedures Work closely with Manufacturing, MSAT, QA, Engineering, and Validation teams Support preparation and execution documentation for process qualification and aseptic process simulations Ensure documentation is aligned with GMP expectations, internal standards, and operational best practices Contribute to training readiness by preparing clear and structured training content for operators and technical teams Provide senior process expertise while remaining hands-on and flexible in document execution activities Support start-up, remediation, or improvement activities related to isolator-based fill & finish operations Profile Requirements: Degree in Life Sciences, Pharmaceutical Sciences, Engineering, or a related technical discipline 10+ years of experience in pharmaceutical manufacturing, with strong expertise in fill & finish / aseptic processing Solid hands-on experience with isolator-based operations Strong knowledge of GMP requirements for sterile manufacturing environments Experience with compounding, smoke studies, media fills, PQ phases, and aseptic process documentation Proven ability to write high-quality SOPs, Work Instructions, training materials, and technical GMP documents Senior profile with the flexibility to perform detailed technical writing activities Strong collaboration skills and ability to interact with shopfloor, QA, Engineering, Validation, and Manufacturing teams Fluent in English; German is a plus Available to start ASAP in the Basel area Why Join Inova? Contribute to a key fill & finish project in a leading pharmaceutical environment Apply your senior aseptic processing expertise in a practical, hands-on documentation role Work closely with cross-functional teams on isolator-based operations Join a dynamic company that values technical excellence, precision, and collaboration How to Apply: Send your application to careers@inova-sa.ch Subject line: Senior Process Expert Fill & Finish – Basel Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.

Position Summary The OPEX & Maintenance Methods Engineer is responsible for improving equipment reliability, manufacturing performance, and maintenance efficiency within a regulated medical device manufacturing environment. The role drives continuous improvement initiatives, optimizes maintenance strategies, and supports operational excellence across Production, Maintenance, Quality, and Engineering teams. Key Responsibilities Improve equipment performance, reliability, OEE, and production yield Lead troubleshooting and root cause analysis activities Define and optimize preventive maintenance strategies and maintenance plans, experience in digital calibration, for digital manufacturing Drive Lean Manufacturing initiatives (5S, Kaizen, continuous improvement) Develop and improve maintenance procedures and work instructions Support maintenance digitalization and performance monitoring tools Collaborate cross-functionally to reduce downtime and improve operational efficiency Support compliance with GMP, ISO 13485, IVDR, and FDA requirements Travail sur nomenclatures des pièces détachées Participate in investigation of deviations, audits, and equipment qualification activities Profile Experienced Technician or Engineering degree in Industrial, Mechanical, Automation, or related field 8+ years of experience in industrial manufacturing environments Strong background in maintenance methods, equipment reliability, and Lean Manufacturing Experience in Medical Device, Diagnostics, or Pharmaceutical industries preferred Strong analytical, troubleshooting, and problem-solving skills Fluent in French and English

Job Description Job Title: Qualification Specialist – Manufacturing Support Company: Inova (www.inova-sa.ch) Location: Lausanne Area, Switzerland Contract Type: Full-time – On-site About Inova: Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high-value expertise in quality, compliance, and digital transformation. We help our clients build robust, future-proof quality systems, from shopfloor execution to enterprise-level governance. Position Overview: We are looking for a Qualification Specialist with a strong generalist background to support manufacturing operations for a leading pharmaceutical client in the Basel area. This role focuses on equipment and utilities qualification across a wide range of systems, including laboratory and production environments (biotech, pharma, and chemical). A significant portion of the activities will involve periodic qualification of utilities, ensuring compliance, performance, and reliability over time. The position requires autonomy, organizational skills, and the ability to define and lead qualification strategies while collaborating with cross-functional teams in a GMP-regulated environment. Key Responsibilities: Execute qualification activities (IQ, OQ, PQ) for production and laboratory equipment Lead initial and re-qualification of equipment across biotech, pharma, and chemical environments Perform and manage periodic qualification of utilities (e.g., HVAC systems, gas networks) Contribute to and define qualification strategies aligned with site and regulatory requirements Support qualification of SIP cycles where applicable Ensure proper documentation in compliance with GMP standards Coordinate with Manufacturing, Engineering, QA, and other stakeholders Plan, organize, and manage qualification activities autonomously Support continuous improvement initiatives within qualification processes Ensure alignment with client culture, values, and operational excellence standards Profile Requirements: Engineering degree or equivalent scientific background Minimum 3 years of experience in qualification within GMP environments Strong hands-on experience with IQ, OQ, and PQ execution Proven experience in qualification of production and laboratory equipment Generalist mindset with the ability to handle diverse systems and environments Experience with SIP cycle qualification is a plus Experience in periodic qualification of utilities (HVAC, gas systems) strongly preferred Ability to define and lead qualification strategies Autonomous, well-organized, and proactive Fluent in French (mandatory) with good understanding of English Willingness to work on-site in the Lausanne area (100% position) Why Join Inova? Work on diverse qualification projects across multiple technologies and environments Play a key role in maintaining compliance and operational excellence in manufacturing Join a dynamic and collaborative team within a leading life sciences hub Contribute to high-impact projects in a GMP-regulated setting How to Apply: Send your application to careers@inova-sa.ch Subject line: Qualification Specialist – Basel Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.