Overview
Senior QA / Cleaning Validation Manager (CAPEX Project) (m/w/d) Jobs in Basel Metropolitan Area at TechFirm Engineering
Title: Senior QA / Cleaning Validation Manager (CAPEX Project) (m/w/d)
Company: TechFirm Engineering
Location: Basel Metropolitan Area
Shape the Future of Pharmaceutical Manufacturing with Techfirm Engineering
For a strategic large-scale CAPEX project at a leading global pharmaceutical manufacturer in Northwestern Switzerland, Techfirm Engineering is looking for an experienced Senior QA / Cleaning Validation Manager to strengthen the Quality Engineering team.
In this key position, you will play a critical role in the GMP-compliant implementation of new manufacturing facilities and ensure that cleaning processes are developed, validated, and maintained according to a risk-based and lifecycle-oriented approach.
KEY RESPONSIBILITIES
- Lead and coordinate Cleaning Validation activities within a major pharmaceutical CAPEX program.
- Develop and implement risk-based Cleaning Validation strategies in accordance with EU GMP, FDA, and ICH requirements.
- Plan, author, review, and approve validation documentation including Validation Master Plans, Protocols, Reports, Risk Assessments, Deviations, and CAPAs.
- Ensure GMP compliance throughout the lifecycle of new manufacturing equipment and processes.
- Drive Change Control, Deviation Management, and CAPA activities related to Cleaning Validation.
- Collaborate closely with Engineering, Manufacturing, MSAT, Quality Control, and other project stakeholders.
- Monitor validation progress and ensure timely execution within demanding project timelines.
- Support internal audits, customer audits, and regulatory inspections.
- Identify opportunities for optimization and continuous improvement of cleaning processes and validation strategies.
YOUR BACKGROUND
- Degree in Chemistry, Pharmacy, Biotechnology, Chemical Engineering, Life Sciences, or a related technical/scientific discipline.
- Minimum 10 years of experience in Cleaning Validation and Quality Assurance within GMP-regulated pharmaceutical or biotech environments.
- Strong experience supporting CAPEX, facility expansion, or greenfield/brownfield projects.
- Deep knowledge of EU GMP, FDA, ICH guidelines, and modern lifecycle validation concepts.
- Proven track record in developing and managing Cleaning Validation programs and documentation.
- Strong understanding of risk management methodologies and validation strategies.
- Excellent stakeholder management skills and experience working in cross-functional project teams.
- Fluent German and good English communication skills.
- Experience with electronic quality systems and documentation platforms (SAP, MasterControl, TrackWise, Veeva, or equivalent).
WHAT WE OFFER
- Opportunity to contribute to one of the most significant pharmaceutical expansion projects in Switzerland.
- High-impact role with significant ownership and visibility.
- Collaboration with experienced experts in Quality, Engineering, and Manufacturing.
- Long-term project perspective within a highly innovative GMP environment.
- Access to Techfirm Engineering's strong Life Sciences network and career development opportunities.
- A collaborative, entrepreneurial, and people-focused company culture.
ABOUT TECHFIRM ENGINEERING
Techfirm Engineering is a Swiss engineering and consulting company supporting major industrial projects across Life Sciences, Energy, Transportation, Construction, and Advanced Manufacturing.
With more than 25 years of experience in the Swiss market, we combine local expertise with an international mindset, delivering high-value engineering and quality solutions for some of the world's leading organizations.
📩 Interested in joining a transformative pharmaceutical project?
Apply directly via LinkedIn or contact Gina Killig for a confidential discussion.
Please note: we can only consider Swiss or EU/EFTA nationals, or candidates holding a valid Swiss work or residence permit.
