Process / Aseptic Validation Engineer - Media Fill

Process / Aseptic Validation Engineer – Media Fill (m/f/d)

Shape the future of pharmaceutical manufacturing with Techfirm Engineering!

For exciting projects within the Swiss pharmaceutical industry, we are seeking an experienced Process / Aseptic Validation Engineer – Media Fill (m/f/d). Do you possess extensive hands-on experience with Media Fill campaigns and aseptic filling processes? Are you eager to apply your expertise in a demanding GMP-regulated environment? We would be delighted to hear from you.

The assignment is based close to Basel. Further details regarding the project location and working arrangements will be shared during an initial discussion.

Your Mission:

In this role, you will support the aseptic process validation of a sterile filling line. You will actively participate in the preparation, execution, monitoring, and follow-up of Media Fill campaigns (Aseptic Process Simulation, APS), ensuring compliance with GMP requirements and applicable contamination control standards.

You will closely collaborate with Production, Quality Assurance, QC Microbiology, and Validation teams to support critical project milestones and to enhance the robustness of aseptic manufacturing processes.

Your Responsibilities:

• Prepare, plan, and execute Media Fill campaigns (APS) in sterile pharmaceutical manufacturing.
• Monitor campaign execution, follow up on results, and collaborate with relevant stakeholders on result assessment.
• Support aseptic process validation activities and contribute to the robustness of aseptic manufacturing processes.
• Ensure compliance with EU GMP Annex 1 and relevant Contamination Control Strategy (CCS) requirements.
• Investigate and manage deviations, contribute to root cause analyses, and support the definition and implementation of appropriate CAPAs.
• Collaborate closely with Production, QA, QC Microbiology, and Validation teams to achieve critical project milestones.
• Support equipment and process qualification activities, particularly Performance Qualification (PQ), where 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). This is a key requirement for the position.
• 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 Techfirm Offers:

• More than 25 years of experience and in-depth knowledge of the Swiss industrial landscape.
• A company with a strong presence across Switzerland and a local approach to project delivery.
• A people-oriented, multicultural, and collaborative working environment.
• Close collaboration between consultants, clients, and project teams.
• Challenging assignments aligned with your skills, experience, and career objectives.
• Long-term, high-quality projects across Life Sciences, Pharma, Industry, and Engineering.
• A strong focus on well-being, professional development, and sustainable collaboration.
• An inclusive workplace committed to equal opportunities and diversity.

Ready for Your Next Challenge?

If you have strong hands-on experience with Media Fill campaigns and would like to contribute your expertise in aseptic process validation within a demanding pharmaceutical environment, apply online using the form below. Please note that only applications matching the job profile will be considered.

Together, we shape the future of pharmaceutical manufacturing at Techfirm Engineering.