QA Engineer – Fill & Finish (m/f/d)

Tech'Firm Industrie AG; Basel; On-site; CHF 110,000 - 160,000; Full time

Job summary

Tech'Firm Industrie AG is seeking a QA Engineer – Fill & Finish (m/f/d) to provide QA support for sterile manufacturing operations near Basel, Switzerland. You will focus on aseptic Fill & Finish processes and ensure compliance with GMP requirements while collaborating with Production, QC Microbiology, Engineering and Validation teams.

Requirements include a Master’s degree, 5+ years in pharmaceutical QA, experience with aseptic manufacturing, and fluency in English (German advantageous).

Qualifications

• Degree or equivalent in Pharmacy, Biotechnology, Process Engineering, Chemistry or related field.
• 5+ years of QA experience in pharmaceutical industry, sterile manufacturing.
• Experience supporting/overseeing aseptic Fill & Finish operations.
• Strong knowledge of GMP, especially EU GMP Annex 1.
• Experience with batch record review, deviation management, root cause analysis, CAPA and change control.
• Isolator/RABS experience a plus; familiarity with Media Fill campaigns, validation and equipment qualification.

Responsibilities

• Provide operational QA support to sterile pharmaceutical manufacturing activities, especially aseptic Fill & Finish operations.
• QA oversight on shopfloor activities; review/approve GMP docs (BMR, SOPs, protocols, reports).
• Ensure compliance with EU GMP Annex 1 and CCS requirements.
• Support deviation investigations, root-cause analyses and CAPAs.
• Participate in change control activities and assess impact on product quality and GMP compliance.
• Collaborate with Production, QC Microbiology, Engineering and Validation teams for QA oversight.
• Support process validation and qualification activities, including Media Fill campaigns (APS).
• Participate in risk assessments and drive continuous improvement in sterile manufacturing.

Skills

GMP compliance

Root cause analysis

CAPA

Deviations management

Change control

Documentation review

Education

Master’s degree ( university of applied sciences )

Tools

Isolator

RABS

Job description

QA Engineer – Fill & Finish (m/f/d)

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

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!

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 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.

Your Responsibilities

• 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.

Your Profile

• 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.

We would be delighted to connect with you!

• Work location 4001 Basel (BS)
• Workload 100%
• Employment start Immediately
• Employment duration Permanent

• Qualification skilled

• Work experience More than 3 years

• Education Master’s degree from a university of applied sciences or equivalent

• English Orally : Very good knowledge Written : Very good knowledge