Process/Aseptic Validation Engineer

Tech'Firm Industrie AG; Basel; On-site; CHF 110,000 - 150,000; Full time

Benefits offered by this job

International working environment

Long-term assignments

Professional development

Collaborative project teams

Job summary

Tech'Firm Industrie AG is seeking an experienced Process/Aseptic Validation Engineer to support Media Fill campaigns on a sterile filling line in Basel, Switzerland. You will ensure GMP compliance and coordinate cross-functional validation activities in a highly regulated environment.

The role requires extensive experience in aseptic processing, media fills, and collaboration with Production, QA, QC Microbiology and Validation teams.

Qualifications

• Degree in Pharmacy, Biotechnology, or related field.
• At least 10 years in sterile pharmaceutical manufacturing.
• Experience with Media Fill campaigns (APS).
• Knowledge of EU GMP Annex 1.
• Strong problem-solving and CAPA capabilities.

Responsibilities

• Coordinate and execute Media Fill campaigns.
• Ensure compliance with EU GMP Annex 1 requirements.
• Collaborate with QA, QC Microbiology and Validation teams.
• Support deviation investigations and CAPA implementations.
• Participate in qualification activities, including PQ.

Skills

Media Fill campaigns

Aseptic validation

GMP compliance

Root cause analysis

CAPA processes

Education

Pharmacy/Biotech/related field

Tools

Isolator technology

RABS technology

PQ equipment

Job description

Process/Aseptic Validation Engineer

Tech'Firm Industrie AG Vacant since : 13.11.2026 Number of jobs : 1 4001 Basel (BS) 100% Immediately Permanent

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

Take the next step in your pharmaceutical engineering career with Techfirm Engineering!

We are currently looking for an experienced Process / Aseptic Validation Engineer – Media Fill (m/f/d) to contribute to exciting projects within the Swiss pharmaceutical industry.

Are you an expert in Media Fill campaigns and aseptic manufacturing processes? Do you thrive in highly regulated GMP environments and enjoy working on technically challenging projects?

Then this could be the perfect opportunity for you!

Location: Near Basel, Switzerland

Additional information regarding the project location and working arrangements will be provided during an initial conversation.

Your Mission

As part of this assignment, you will play a key role in supporting the validation of aseptic processes on a sterile pharmaceutical filling line. Your 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). 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

• 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.

Please note: only candidates with valid Swiss/EU/EFTA work authorization can be considered.

By email: [e-mail]