Technical lead role in a regulated manufacturing environment, responsible for securing, maintaining and improving OT systems and industrial infrastructure, bridging OT and IT, leading OT cybersecurity and OT/IT convergence projects, and supporting digital transformation on site.

# QA Governance & Policy Writer **Location:** Basel Area, Switzerland **Contract Type:** Full-time – On-site **Start Date:** ASAP **Industry:** Pharmaceutical / Life Sciences **Experience:** Minimum 10 years in Pharmaceutical Quality Assurance ## About Inova Inova is a Swiss consulting and engineering company supporting Life Sciences organizations with high-value expertise across Quality, Compliance, Engineering, Automation and Digital Transformation. For one of our pharmaceutical clients in the Basel area, we are looking for a senior **QA Governance & Policy Writer** to support the implementation and structuring of a new Quality Management System. ## Position Overview The consultant will play a key role in building the company's **Quality Governance framework** ahead of regulatory inspection and the start of pharmaceutical manufacturing operations. This is not only a technical writing position. We are looking for a senior QA professional able to **challenge, structure and define the right level of Quality Governance**, while also taking hands-on ownership of the documentation required to implement it. The role covers the definition and drafting of **Quality Policies, Master Documents, governance documents and SOPs** within a newly established QMS. ## Key Responsibilities * Structure and strengthen the overall **Quality Governance framework** * Define clear governance principles, responsibilities, decision-making and escalation mechanisms * Develop and write **Quality Policies, Master Documents, SOPs and other QMS documentation** * Ensure consistency and hierarchy across the different levels of Quality documentation * Challenge existing concepts and propose pragmatic, compliant Quality solutions * Translate regulatory and corporate Quality requirements into clear and operational documentation * Support the implementation and maturation of the new **Quality Management System** * Identify documentation and governance gaps ahead of regulatory inspection * Ensure documentation is inspection-ready and suitable for the transition into routine manufacturing operations * Collaborate closely with Quality leadership and relevant business functions ## Profile * **Minimum 10 years of experience in Pharmaceutical Quality Assurance** * Strong experience in **Quality Governance and QMS implementation or transformation** * Demonstrated experience developing **Quality Policies, Master Documents, governance frameworks and SOPs** * Excellent understanding of pharmaceutical **GMP and Quality Systems** * Previous experience supporting a **new site, new organization, QMS build-up or major Quality transformation** is highly valued * Able to operate at both strategic and execution levels: defining the framework and writing the documentation * Strong critical thinking and ability to challenge existing approaches constructively * Excellent technical and procedural writing capabilities * Senior, autonomous and delivery-oriented * **Fluent English required; no additional language required** ## Project Environment This is a hands-on senior Quality role within a fast-moving pharmaceutical organization preparing simultaneously for **regulatory inspection, QMS implementation and production launch**. The ideal consultant combines **Quality Governance expertise, strong GMP judgement and excellent technical writing skills**, with the ability to turn Quality principles into a robust and operational documentation framework.

Job Title: Aseptic Manufacturing Process Expert – Fill & Finish 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, engineering, and digital transformation. We help our clients deliver robust, compliant, and future-ready pharmaceutical operations, from shopfloor execution to process and quality governance. Position OverviewWe are seeking an experienced Aseptic Manufacturing Process Expert – Fill & Finish to support a pharmaceutical client in the Basel area.This role will provide senior process expertise across aseptic manufacturing and fill & finish operations, with a particular focus on isolator-based filling processes, compounding, aseptic process simulations, qualification activities, and operational readiness.The successful candidate will combine strong hands-on manufacturing experience with a deep understanding of GMP requirements for sterile production. You will work closely with Manufacturing, MSAT, QA, Engineering, and Validation teams to support process readiness, qualification, troubleshooting, continuous improvement, and the development of robust operational documentation.The role requires a pragmatic expert who is comfortable working close to shopfloor operations while also providing technical leadership and translating complex aseptic processes into clear and compliant procedures. Key Responsibilities Provide senior technical expertise for aseptic manufacturing and fill & finish processes Support isolator-based filling operations, including process setup, preparation, execution, and continuous improvement Provide process expertise for compounding, aseptic filling, interventions, cleaning, decontamination, and associated manufacturing activities Support the preparation, execution, and assessment of aseptic process simulations / media fills Contribute to smoke studies / airflow visualization studies and assessment of aseptic practices and interventions Support process qualification and performance qualification (PQ) activities related to fill & finish operations Assess manufacturing processes and identify opportunities to improve aseptic robustness, operational reliability, and GMP compliance Support troubleshooting and investigation of process-related issues, deviations, and operational challenges Provide technical input into risk assessments, contamination control measures, and aseptic process improvements Write, review, and improve GMP documentation, including SOPs, Work Instructions, training materials, protocols, and operational guidance Translate practical manufacturing knowledge into clear, effective, and shopfloor-oriented procedures Support operator training and manufacturing readiness for new or updated processes Collaborate closely with Manufacturing, MSAT, QA, Engineering, Validation, and Sterility Assurance teams Support start-up, remediation, technology transfer, or continuous improvement activities within fill & finish operations Ensure activities and documentation are aligned with applicable GMP requirements, internal standards, and industry best practices Profile Requirements Degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or a related technical discipline 10+ years of experience in pharmaceutical manufacturing, with significant expertise in aseptic processing and fill & finish Strong hands-on experience with sterile manufacturing operations and isolator-based filling technologies In-depth understanding of GMP requirements and aseptic manufacturing principles Practical experience with compounding, aseptic filling, isolator operations, interventions, and routine manufacturing activities Strong experience with media fills / aseptic process simulations, smoke studies, and qualification activities Experience supporting PQ phases, manufacturing readiness, or start-up activities Good understanding of contamination control and sterility assurance principles within aseptic manufacturing Proven ability to troubleshoot manufacturing processes and provide pragmatic technical solutions Experience writing and reviewing SOPs, Work Instructions, training materials, protocols, and technical GMP documentation Ability to combine a senior expert perspective with a hands-on and operational mindset Strong communication and collaboration skills across shopfloor and technical functions Fluent in English; German is a plus Available to start ASAP in the Basel area Why Join Inova? Contribute to a key aseptic fill & finish project within a leading pharmaceutical environment Apply your senior manufacturing expertise directly to isolator-based operations and shopfloor processes Work across process readiness, qualification, troubleshooting, documentation, and continuous improvement Collaborate with experienced cross-functional teams across Manufacturing, MSAT, QA, Engineering, and Validation Join a dynamic company that values technical excellence, autonomy, precision, and collaboration Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.

Project Engineering Leader for Bio and Pharma engineering projects in a GMP-regulated environment. The role is the central point of contact for the project, coordinating stakeholders, managing schedule and budget, reviewing specifications, challenging technical disciplines, and ensuring alignment with technical, safety, environmental, and GMP standards.

Support the daily operation of automated equipment in a pharmaceutical production site manufacturing active ingredients and intermediates, ensuring reliable and compliant operation in coordination with production, logistics, and maintenance teams. About Inova Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high-value expertise in quality, compliance, engineering, and digital transformation. We help our clients strengthen their operational capabilities and build robust, inspection-ready quality systems across manufacturing environments. Role title Automation Engineer Context Within a pharmaceutical production site, you support the day-to-day operation of automated equipment used to manufacture active ingredients and intermediates. Your mission is to keep automated systems running reliably, in compliance with procedures, and in close coordination with production, logistics and maintenance teams. Your missions Operate and support the automated systems and technical equipment used in production Build and maintain solid working knowledge of the equipment, machines and associated procedures Ensure manufacturing operations for intermediates and active ingredients are carried out according to defined processing frameworks Contribute to standard assembly and manufacturing operations, respecting quality and safety requirements Work closely with colleagues across production, transport and storage areas Support front-line logistics activities: order management, internal customer service and distribution, within defined processes Report deviations, anomalies and improvement opportunities on automated systems What it takes to succeed Rigorous application of procedures in a regulated manufacturing environment Ability to communicate clearly with operators, engineers and support functions on a daily basis Hands-on, proactive mindset: you go to the field, you follow through Coordination skills to keep several teams aligned around equipment availability Fast learning curve on new equipment and control systems Profile required 2 to 3 years of experience minimum as an Automation Engineer, ideally in the operation of automated technical equipment Junior profiles considered: recent graduates with relevant practical experience (apprenticeship, internship in an industrial environment) Technical education in automation, electrical engineering, instrumentation and control, or equivalent Experience in an industrial or pharmaceutical production environment is a strong asset Fluent English is mandatory; German is a strong advantage Key competencies OT / SCADA systems E&IC (electrical, instrumentation and control) DeltaV and/or Siemens control systems Understanding of manufacturing and logistics processes in a regulated environment Communication, coordination and teamwork Autonomy and sense of ownership Why this mission This is an opportunity to work at the heart of a pharmaceutical production environment, on automated systems that directly support the manufacturing of active ingredients. You will gain broad exposure across production, engineering and supply chain teams, in a role where your field presence and your ability to connect people make an immediate, visible difference.

Industrial Automation Project Engineer, German Speaking Company: Inova Location: Swiss German Area, Switzerland Work Model: Predominantly on-site Start Date: September 2026 About Inova Inova is a Swiss consulting and engineering firm supporting life sciences and industrial companies with expertise in engineering, automation, quality, compliance, and digital transformation. Position Overview We are looking for an experienced Industrial Automation Project Engineer to support a major industrial project in the Swiss German Area. Work language is German. You will take ownership of automation and instrumentation activities from Detailed Design through installation and commissioning, working closely with engineering teams, contractors, suppliers, and project stakeholders. The role combines automation, instrumentation & control, electrical engineering, process safety, and IT/OT, with a strong focus on practical field execution and commissioning. Key Responsibilities Develop and maintain MSRL / instrumentation and control lists Prepare and review functional descriptions and Cause & Effect diagrams Support the plant automation concept and architecture Specify and assess instrumentation, control devices, and valves Review P&IDs, process diagrams, and electrical schematics Ensure alignment between process, automation, instrumentation, and electrical design Support process risk assessments, SIL, and Performance Level (PL) requirements Review and challenge solutions from engineering partners and contractors Coordinate installation, contractors, and commissioning activities Perform functional checks, troubleshooting, and field support Ensure compliance with applicable IT/OT and automation standards Profile Requirements Professional proficiency in German and English Degree in Automation, Electrical, Mechanical, Mechatronics Engineering, or similar Minimum 5 years of experience in industrial automation or plant engineering Strong experience with instrumentation, MSRL, P&IDs, and field engineering Good knowledge of SIL / PL and process safety principles Ability to read electrical schematics Experience with installation, commissioning, and contractor coordination Experience with Siemens TIA Portal, SIMATIC S7, and/or WinCC is a strong advantage Knowledge of AutoCAD 2D / P&ID is desirable Background in food, chemical, pharmaceutical, or process industries preferred Spray drying or brownfield project experience is an additional asset Autonomous, structured, hands-on, and solution-oriented Available for a predominantly on-site assignment in the Swiss German Area Why Join Inova? Take ownership of a key industrial automation project Work from engineering design through commissioning Combine technical design with hands-on field activities Join a dynamic Swiss engineering team with strong technical expertise Inova is an equal opportunity employer and is committed to fostering an inclusive workplace.

Consulting mission for a composite technician at Inova Consulting to rapidly prototype carbon structures from mold to finished and inspected part, design simple fixtures and tooling, and support assembly, documentation, and process improvement in an industrial/composite workshop environment.

Context The Project Engineer develops technical concepts and advises stakeholders on key decisions, from feasibility through execution. The role owns detail engineering, budget requests, and project delivery, and is accountable for deadlines, costs, and functionality. For medium-sized projects, the Project Engineer also coordinates internal and external engineering support resources. Your missions Lead technical project management for small and medium-sized investment projects that directly impact ongoing production and business results. Perform process engineering calculations and plant optimizations. Conduct feasibility studies for new plants and rebuilds of existing plants, including cost estimation, scheduling, and functionality assessment. Plan, execute, and support production adjustments and product launches. Develop and evaluate possible technical solutions, weighing advantages and disadvantages. Procure and organize the internal or external resources needed for professional, on-time project execution. What it takes to succeed Strong sense of ownership for deadlines, costs, and functional outcomes. Ability to translate technical options into clear, actionable recommendations. Comfort coordinating cross-functional and external resources in a matrix setup. Structured, independent, and flexible way of working. Profile required 3 to 10 years of work experience in a GMP environment, on projects ranging from CHF 10K to 200K. Degree from a technical college or university, ideally in mechanical engineering, process technology, or bio/chemical engineering. Demonstrated application of professional knowledge and training in daily work. Key competencies Very good communication skills. Advanced written and spoken English and German. Excellent leadership skills in a matrix organization. Solid understanding of business and financial processes. Solution-oriented and structured approach, with strong comprehension of complex contexts. Highly motivated and self-driven.