Aseptic Validation Engineer: Media Fill Specialist

Tech'Firm Industrie AG; Basel; On-site; CHF 120,000 - 160,000; Full time

Job summary

Tech'Firm Industrie AG is seeking an experienced Process / Aseptic Validation Engineer – Media Fill (m/f/d) near Basel. You will validate aseptic filling processes and lead Media Fill campaigns in a GMP-regulated environment.

You will work with Production, Quality Assurance, QC Microbiology and Validation teams to achieve milestones and ensure process robustness. Extensive hands-on APS experience is essential for this role.

Qualifications

• Degree in Pharmacy, Biotechnology, Process Engineering, Chemistry or a related field.
• At least 10 years in sterile pharmaceutical manufacturing, especially aseptic Fill & Finish.
• Hands-on experience with Media Fill campaigns (APS) and aseptic validation.
• Strong knowledge of EU GMP Annex 1 and contamination control strategies.
• Experience with isolator or RABS technologies and deviation management.
• Familiar with PQ qualification activities and CAPA processes.
• Independent, structured, cross-functional teamwork and GMP communication.

Responsibilities

• Prepare, plan and execute Media Fill campaigns in sterile manufacturing.
• Monitor campaigns, assess results and coordinate with stakeholders.
• Support aseptic process validation activities and robustness of processes.
• Ensure compliance with EU GMP Annex 1 and CCS requirements.
• Investigate deviations, drive root cause analyses and CAPA.
• Collaborate with Production, QA, QC Microbiology, Validation teams.
• Assist with PQ qualification activities where required.

Education

Degree in Pharmacy, Biotechnology, Process Engineering, Chemistry or related field

Tools

SKAN

Syntegon

Groninger

Bausch+Strobel

Optima

Vanrx

Isolator

RABS

Job description

Tech'Firm Industrie AG is seeking an experienced Process / Aseptic Validation Engineer – Media Fill (m/f/d) near Basel. You will validate aseptic filling processes and lead Media Fill campaigns in a GMP-regulated environment.

You will work with Production, Quality Assurance, QC Microbiology and Validation teams to achieve milestones and ensure process robustness. Extensive hands-on APS experience is essential for this role.