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

h3bProcess / Aseptic Validation Engineer – Media Fill (m/f/d) /b /h3 pTech'Firm Industrie AG Vacant since : Number of jobs : 1 4001 Basel (BS) 100% Immediately Permanent /p pShape the future of pharmaceutical manufacturing with Techfirm Engineering! /p pFor 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. /p pThe assignment is based close to Basel. Further details regarding the project location and working arrangements will be shared during an initial discussion. /p h3Your Mission: /h3 pIn 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. /p pYou 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. /p h3Your Responsibilities: /h3 ul liPrepare, plan and execute Media Fill campaigns (APS) in sterile pharmaceutical manufacturing. /li liMonitor campaign execution, follow up on results and collaborate with relevant stakeholders on result assessment. /li liSupport aseptic process validation activities and contribute to the robustness of aseptic manufacturing processes. /li liEnsure compliance with EU GMP Annex 1 and relevant Contamination Control Strategy (CCS) requirements. /li liInvestigate and manage deviations, contribute to root cause analyses and support the definition and implementation of appropriate CAPAs. /li liCollaborate closely with Production, QA, QC Microbiology and Validation teams to achieve critical project milestones. /li liSupport equipment and process qualification activities, particularly Performance Qualification (PQ), where required. /li /ul h3Your Profile: /h3 ul liDegree or equivalent qualification in Pharmacy, Biotechnology, Process Engineering, Chemistry or a related scientific or technical field. /li liAt least 10 years of experience in sterile pharmaceutical manufacturing, particularly in aseptic Fill Finish processes. /li liProven hands‑on experience in the preparation, execution and follow‑up of Media Fill campaigns (APS). This is a key requirement for the position. /li liStrong knowledge of aseptic process validation and EU GMP Annex 1 requirements. /li liExperience working with isolator and/or RABS technologies. /li liGood understanding of contamination control strategies, deviation management, root cause analysis and CAPA processes. /li liExperience with filling line equipment from manufacturers such as SKAN, Syntegon, Groninger, Bausch+Ströbel, Optima or Vanrx is an advantage. /li liExperience in qualification activities, particularly Performance Qualification (PQ), is desirable. /li liIndependent, structured and solution‑oriented working style, with the ability to collaborate effectively across multidisciplinary teams. /li liGood communication skills in a GMP‑regulated environment. /li /ul h3What Techfirm Offers: /h3 ul liMore than 25 years of experience and in-depth knowledge of the Swiss industrial landscape. /li liA company with a strong presence across Switzerland and a local approach to project delivery. /li liA people‑oriented, multicultural and collaborative working environment. /li liClose collaboration between consultants, clients and project teams. /li liChallenging assignments aligned with your skills, experience and career objectives. /li liLong‑term, high‑quality projects across Life Sciences, Pharma, Industry and Engineering. /li liA strong focus on well‑being, professional development and sustainable collaboration. /li liAn inclusive workplace committed to equal opportunities and diversity. /li /ul pBy email: /p pTogether, we shape the future of pharmaceutical manufacturing at Techfirm Engineering. /p #J-18808-Ljbffr