Job Description Job Title: CSV & QA Compliance Specialist – Validation Assessment & Remediation Company: Inova (www.inova-sa.ch) Location: Basel Area, Switzerland Contract Type: Full-time – On-site About Inova Inova is a Swiss consulting and engineering firm specialized in supporting life sciences industries through high-value expertise in quality, compliance, engineering, and digital transformation. We partner with pharmaceutical and biotech companies to strengthen compliance, optimize validation strategies, and ensure operational excellence across regulated environments. Position Overview We are seeking a CSV & QA Compliance Specialist to support a pharmaceutical client in the Basel area with validation assessment, remediation activities, and quality oversight of computerized systems used across the organization. This role requires a hands-on CSV professional capable of autonomously conducting assessments of various GxP systems, evaluating historical validation documentation, identifying compliance gaps, and driving corrective actions in collaboration with QA, IT, Engineering, and business stakeholders. The ideal candidate combines strong technical CSV expertise with quality and compliance mindset, including deviation management, CAPAs, audit readiness, and change control activities within a GMP-regulated environment. Key Responsibilities Conduct autonomous CSV assessments of computerized systems across GxP environments Evaluate validation status and compliance of systems used in manufacturing, laboratories, QA, and business operations Review historical validation documentation and identify remediation or corrective actions Assess executed test scripts and coordinate test review and re-execution when required Support and manage deviations, investigations, and CAPA activities linked to CSV compliance gaps Participate in and support Change Control activities related to computerized systems Ensure alignment with GAMP 5, Annex 11, 21 CFR Part 11, and data integrity requirements Collaborate cross-functionally with QA, IT, Engineering, and system owners Contribute to audit readiness activities and support internal and external inspections Provide risk-based recommendations for validation lifecycle improvements Support continuous improvement initiatives related to CSV and compliance processes Why Join Inova? Join impactful pharmaceutical compliance and digital quality projects Work on diverse GxP systems and complex validation environments Be part of a collaborative and highly specialized consulting team Contribute to quality excellence and compliance strategy within leading life sciences organizations Grow within a company that values expertise, autonomy, and innovation How to Apply Send your application to careers@inova-sa.ch Subject line: CSV & QA Compliance Specialist – Basel Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.

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.

Job Description Job Title: Plant Engineer – Facilities & Utilities Company: Inova (www.inova-sa.ch) Location: Neuchâtel 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 systems across manufacturing, engineering, and quality environments. Position Overview: We are seeking a Plant Engineer specialized in Facilities & Utilities to support a leading pharmaceutical client in the Neuchâtel area. In this role, you will act as a Subject Matter Expert (SME) ensuring the reliability, compliance, and continuous improvement of site-wide infrastructure and utility systems. You will play a key role in maintaining operational excellence by supporting investigations, driving technical optimizations, and contributing to engineering projects across the site. Working at the interface of engineering, operations, and quality, you will ensure that all systems meet cGxP, safety, and regulatory expectations while supporting ongoing production activities. Key Responsibilities: Act as SME for Facilities & Utilities systems, supporting users on technical topics Provide expertise in building systems, HVAC, black utilities (chillers, boilers), clean utilities, and chemical storage/distribution Lead or support design, installation, commissioning, and qualification of equipment and system upgrades Ensure systems and installations remain in a compliant and fit-for-use state, proactively identifying improvement opportunities Manage and coordinate corrective actions, technical investigations, and continuous improvement initiatives Ensure alignment with cGMP, Good Engineering Practices (GEP), and relevant standards (SUVA, ASIT, etc.) Develop and implement engineering procedures and ensure adherence to company and corporate standards Support cross-functional projects impacting site infrastructure and operations Participate in internal and external audits as Facilities & Utilities expert Promote and ensure high safety standards across all activities Profile Requirements: Engineering degree (BSc, MSc or equivalent) in Mechanical Engineering, Biotechnology, Chemistry, or related field Minimum 5 years of experience in Pharma/Biotech engineering environments Strong experience with Facilities & Utilities systems in GMP environments Hands-on experience with installation, commissioning, and qualification of pharmaceutical equipment and systems Knowledge of cGxP, GEP, FDA, ISPE guidelines, ASTM E2500, and ASME/BPE standards Experience in maintenance and utilities is a plus Fluent in French and English (German is an asset) Proficient with MS Office and MS Project Strong problem-solving skills and technical mindset Team-oriented, proactive, and comfortable in a fast-paced environment Hands-on, action-driven, and adaptable Why Join Inova? Contribute to critical infrastructure of a leading pharmaceutical site Work at the heart of engineering, operations, and compliance Be involved in both day-to-day technical support and impactful improvement projects Join a collaborative and expert-driven environment Grow your expertise in a highly regulated and innovative industry How to Apply: Send your application to careers@inova-sa.ch Subject line: Plant Engineer – Neuchâtel Inova is an equal opportunity employer. We value diversity and are committed to creating an inclusive workplace.