QA Engineer – Fill & Finish (m/f/d)

Quality Assurance Support for Sterile Pharmaceutical Manufacturing

Take the next step in your pharmaceutical engineering career by contributing to exciting projects within the Swiss pharmaceutical industry. This role is designed for experienced Quality Assurance professionals with a strong background in aseptic Fill & Finish operations who thrive in highly regulated GMP environments. The position offers the opportunity to support manufacturing teams while ensuring the highest quality standards in a welcoming, people-focused, and international working environment.

Your Mission

Play a key role in providing Quality Assurance support to sterile pharmaceutical manufacturing operations, with a particular focus on aseptic Fill & Finish processes. The main responsibility is to ensure that manufacturing activities are performed in compliance with applicable GMP requirements, internal quality standards, and regulatory expectations. Working closely with Production, QC Microbiology, Engineering, and Validation teams, you will provide hands-on QA support, oversee critical manufacturing activities, and contribute to the resolution of quality-related issues. This role is vital for maintaining product quality, ensuring GMP compliance, and supporting the reliability of sterile manufacturing operations.

Your Responsibilities

• Provide operational Quality Assurance support to sterile pharmaceutical manufacturing activities, particularly within aseptic Fill & Finish operations.
• Perform QA oversight of manufacturing activities and provide quality guidance to Production teams on the shop floor.
• Review and approve GMP documentation, including batch manufacturing records, SOPs, protocols, and reports.
• Ensure compliance with EU GMP Annex 1 and applicable Contamination Control Strategy (CCS) requirements.
• Support the management and investigation of deviations, perform root cause analyses, and contribute to the implementation of effective CAPAs.
• Participate in change control activities and assess their potential impact on product quality and GMP compliance.
• Collaborate with Production, QC Microbiology, Engineering, and Validation teams to ensure appropriate quality oversight throughout manufacturing operations.
• Support process validation and qualification activities, including Media Fill campaigns (APS), when required.
• Participate in risk assessments and contribute to continuous improvement initiatives within sterile manufacturing operations.

Your Profile

• Degree or equivalent qualification in Pharmacy, Biotechnology, Process Engineering, Chemistry, or a related scientific or technical field.
• At least 5 years of experience in Quality Assurance within the pharmaceutical industry, particularly in sterile pharmaceutical manufacturing.
• Proven experience supporting or overseeing aseptic Fill & Finish operations, which is a key requirement for the position.
• Strong knowledge of GMP regulations, particularly EU GMP Annex 1 requirements.
• Experience in batch record review, deviation management, root cause analysis, CAPA, and change control processes.
• Good understanding of aseptic manufacturing processes and contamination control principles.
• Experience working with isolator and/or RABS technologies is an advantage.
• Familiarity with Media Fill campaigns (APS), process validation, and equipment qualification activities is desirable.
• Experience providing hands-on QA support in manufacturing environments and interacting with multidisciplinary teams.
• Independent, structured, and solution-oriented working style, with the ability to make sound quality decisions in a GMP-regulated environment.
• Good communication skills and the ability to collaborate effectively with Production, QC, Engineering, and Validation teams.
• Fluency in English is required; German is an advantage.

What We Offer

• Over 25 years of expertise supporting engineering and industrial projects across Switzerland.
• An established presence in the Swiss market, combining local expertise with a strong national network.
• A welcoming, people-focused, and international working environment.
• Close cooperation with consultants, clients, and multidisciplinary project teams.
• Opportunities to contribute to challenging projects tailored to your expertise and professional ambitions.
• Access to long-term, high-quality assignments across Life Sciences, Pharmaceuticals, Industry, and Engineering.
• A commitment to employee well-being, continuous professional development, and long-term collaboration.
• A diverse and inclusive workplace that values equal opportunities and individual contributions.