Validation Manager / Cleaning Engineer: Biotechnology MSAT / Cleaning / Sterilization / Validation / Qualification / Validation / Veeva / eVAL German / English /
Project:
For our client, a large pharmaceutical company based in Basel, we are looking for a Validation Manager / Cleaning Engineer
Background:
Basel Drug Substance Manufacturing produces biotechnological "Large Molecule" APIs (Active Pharmaceutical Ingredients) for commercial and clinical supply in two production buildings on different scales.
The ideal candidate is a flexible team player with a strong sense of responsibility and a willingness to take ownership, and possesses relevant experience in validation. More than five years of professional experience in the pharmaceutical industry in a production, development, or quality management role are required, as well as over three years of experience in qualification and validation, particularly sterilization and cleaning validation and equipment qualification. Excellent written and verbal communication skills in German and English are essential. Other desirable qualities include a friendly demeanor, strong communication skills, a deep understanding of GMP, a commitment to quality, and technical/scientific expertise in cleaning and sterilization processes, including autoclaves.
Tasks & Responsibilities :
As a Validation Manager in the MSAT Cleaning & Sterilization Validation team, you will be responsible for the following tasks:
• Creating qualification and validation documents in the area of cleaning and sterilization validation (plans, reports)
• Supporting validation activities, in particular coordination within the interdisciplinary team and communication with stakeholders
• Verifying equipment and ensuring release for production • Processing changes, deviations, and CAPAs (Corrective and Preventive Actions), as well as creating technical
assessments for stakeholders
• Supporting regulatory documents and reporting procedures
• Collaborating with partners from site engineering, manufacturing plants, and QA/QC departments
• Working in an environment with strong team spirit, timely and effective
communication, a sense of urgency, and high motivation to achieve operational goals
• Representing qualification and validation topics during regulatory inspections
Must-haves:
• Bachelor's, Master's, or equivalent higher degree in natural sciences, engineering, biotechnology, or a related field
• Minimum of 5 years of professional experience in the pharmaceutical industry in a production, development, or quality function
• Minimum of 3 years of experience with qualification and validation, particularly sterilization and cleaning validation, and equipment qualification
• You impress with your structured, solution-oriented, and independent work style, as well as your analytical thinking skills.
• You have a quick grasp of new concepts, enjoy working in a team, and demonstrate commitment and initiative.
• You possess strong oral and written communication skills in German and English
. • You have a confident, ethical, and competent demeanor and the ability to exert influence at all levels.
• You take ownership of your own area of responsibility.
Nice to have:
• Experience with autoclaves/steam sterilizers
• Knowledge of Roche IT systems ( Veeva, eVAL)
Reference No.: 924959
Role: Validation Manager
Industry: Pharmaceuticals
Location: Basel
Workload: 80-100%
Start: ASAP (September 1, 2026)
Duration: 9+ Months
Application Deadline: May 26, 2026
If this position has sparked your interest, please send us your complete application. If this position isn't quite the right fit and you'd prefer to be notified about other opportunities, you can also submit your application via this advertisement or to jobs[at]itcag[dot]com.
For more information about our company, our open positions, or our attractive payroll-only program, please contact us at .
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with branches in Germany and Ireland. ITech Consult speciali j4id10218451a j4it0521a j4iy26a