QA Engineer – Fill & Finish (m/f/d)

TechFirm Engineering; Basel; On-site; CHF 90,000 - 130,000; Full time

Job summary

Techfirm Engineering is seeking an experienced QA Engineer – Fill & Finish (m/f/d) to provide Quality Assurance support for sterile pharmaceutical manufacturing in Switzerland. The role focuses on aseptic Fill & Finish operations, ensuring GMP compliance and collaboration with Production, QC Microbiology, Engineering and Validation teams.

Responsibilities include reviewing batch records and SOPs, supporting deviation investigations, CAPAs, and change controls, and contributing to continuous

Qualifications

• Degree in Pharmacy, Biotechnology, Process Engineering, Chemistry or a related field.
• At least 5 years of QA experience in the pharmaceutical industry, especially sterile manufacturing.

Responsibilities

• Provide QA support to sterile manufacturing activities, especially aseptic Fill & Finish.
• Oversee manufacturing activities and review GMP docs on the shop floor.
• Ensure compliance with EU GMP Annex 1 and CCS requirements.
• Investigate deviations, perform root cause analyses and contribute to CAPAs.
• Participate in change controls and assess impact on product quality.

Skills

QA Oversight

GMP Compliance

Aseptic Processing

Root Cause Analysis

CAPA

Education

Pharmacy or related field

Sterile manufacturing experience

Tools

GMP Documentation Review

Job description

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

We are currently looking for an experienced QA Engineer – Fill & Finish (m/f/d) to contribute to exciting projects within the Swiss pharmaceutical industry.

Are you an experienced Quality Assurance professional with a strong background in aseptic Fill & Finish operations? Do you thrive in highly regulated GMP environments and enjoy supporting manufacturing teams while ensuring the highest quality standards?

Then this could be the perfect opportunity for you!

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

As part of this assignment, you will play a key role in providing Quality Assurance support to sterile pharmaceutical manufacturing operations, with a particular focus on aseptic Fill & Finish processes.

Your main responsibility will be to ensure that manufacturing activities are performed in compliance with applicable GMP requirements, internal quality standards and regulatory expectations. Working closely with Production, QC Microbiology, Engineering and Validation teams, you will provide hands‑on QA support, oversee critical manufacturing activities and contribute to the resolution of quality‑related issues.

You will play an important role in maintaining product quality, ensuring GMP compliance and supporting the reliability of sterile manufacturing operations.

• Provide operational Quality Assurance support to sterile pharmaceutical manufacturing activities, particularly within aseptic Fill & Finish operations.
• Perform QA oversight of manufacturing activities and provide quality guidance to Production teams on the shop floor. Review and approve GMP documentation, including batch manufacturing records, SOPs, protocols and reports.
• Ensure compliance with EU GMP Annex 1 and applicable Contamination Control Strategy (CCS) requirements.
• Support the management and investigation of deviations, perform root cause analyses and contribute to the implementation of effective CAPAs.
• Participate in change control activities and assess their potential impact on product quality and GMP compliance.
• Collaborate with Production, QC Microbiology, Engineering and Validation teams to ensure appropriate quality oversight throughout manufacturing operations.
• Support process validation and qualification activities, including Media Fill campaigns (APS), when required.
• Participate in risk assessments and contribute to continuous improvement initiatives within sterile manufacturing operations.
• Degree or equivalent qualification in Pharmacy, Biotechnology, Process Engineering, Chemistry or a related scientific or technical field.
• At least 5 years of experience in Quality Assurance within the pharmaceutical industry, particularly in sterile pharmaceutical manufacturing.
• Proven experience supporting or overseeing aseptic Fill & Finish operations. This is a key requirement for the position.
• Strong knowledge of GMP regulations, particularly EU GMP Annex 1 requirements.
• Experience in batch record review, deviation management, root cause analysis, CAPA and change control processes. Good understanding of aseptic manufacturing processes and contamination control principles.
• Experience working with isolator and/or RABS technologies is an advantage. Familiarity with Media Fill campaigns (APS), process validation and equipment qualification activities is desirable.
• Experience providing hands‑on QA support in manufacturing environments and interacting with multidisciplinary teams.
• Independent, structured and solution‑oriented working style, with the ability to make sound quality decisions in a GMP-regulated environment.
• Good communication skills and the ability to collaborate effectively with Production, QC, Engineering and Validation teams.
• Fluency in English is required ; German is an advantage.

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.

Ready to Explore Your Next Opportunity?

Are you passionate about Quality Assurance and experienced in aseptic Fill & Finish operations? Would you like to apply your expertise to technically demanding pharmaceutical projects in Switzerland?

We would be delighted to connect with you!