Process/Aseptic Validation Engineer

Advance Your Career in Pharmaceutical Engineering

Take the next step in your pharmaceutical engineering career by contributing to exciting projects within the Swiss pharmaceutical industry. This role is designed for experts in Media Fill campaigns and aseptic manufacturing processes who thrive in highly regulated GMP environments and enjoy working on technically challenging projects.

Your Mission

Play a key role in supporting the validation of aseptic processes on a sterile pharmaceutical filling line. The main focus will be the planning, preparation, execution, and follow-up of Media Fill campaigns (Aseptic Process Simulation – APS), ensuring that all activities meet applicable GMP and contamination control requirements. Working alongside Production, Quality Assurance, QC Microbiology, and Validation teams, you will contribute to the successful delivery of critical project milestones and the reliability of aseptic manufacturing operations.

Your Responsibilities

• Coordinate and actively participate in the preparation, planning, and execution of Media Fill campaigns (APS) within sterile manufacturing operations.
• Oversee campaign activities, monitor execution, and collaborate with relevant teams to review and assess results.
• Contribute to aseptic process validation activities, ensuring consistent and reliable manufacturing processes.
• Maintain compliance with EU GMP Annex 1 and applicable Contamination Control Strategy (CCS) requirements.
• Support the investigation of deviations, perform root cause analyses, and contribute to the implementation of effective CAPAs.
• Work closely with Production, QA, QC Microbiology, and Validation to support project objectives and timelines.
• Participate in equipment and process qualification activities, including Performance Qualification (PQ), when required.

Your Profile

• Degree or equivalent qualification in Pharmacy, Biotechnology, Process Engineering, Chemistry, or a related scientific or technical field.
• At least 10 years of experience in sterile pharmaceutical manufacturing, particularly in aseptic Fill & Finish processes.
• Proven hands-on experience in the preparation, execution, and follow-up of Media Fill campaigns (APS).
• Strong knowledge of aseptic process validation and EU GMP Annex 1 requirements.
• Experience working with isolator and/or RABS technologies.
• Good understanding of contamination control strategies, deviation management, root cause analysis, and CAPA processes.
• Experience with filling line equipment from manufacturers such as SKAN, Syntegon, Groninger, Bausch+Ströbel, Optima, or Vanrx is an advantage.
• Experience in qualification activities, particularly Performance Qualification (PQ), is desirable.
• Independent, structured, and solution-oriented working style, with the ability to collaborate effectively across multidisciplinary teams.
• Good communication skills in a GMP-regulated environment.

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.