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

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 looking for an experienced Process / Aseptic Validation Engineer – Media Fill (m/f/d). Do you have extensive hands-on experience with Media Fill campaigns and aseptic filling processes? Are you looking to apply your expertise in a demanding GMP-regulated environment? Then 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 play an active role in the preparation, execution, monitoring and follow-up of Media Fill campaigns (Aseptic Process Simulation, APS), helping to ensure compliance with GMP requirements and applicable contamination control standards.

You will work closely with Production, Quality Assurance, QC Microbiology and Validation teams to support critical project milestones and ensure 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, we would be pleased to receive your application or hear from you directly on LinkedIn via Mathilde GEORGLER.

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