As a Teamlead CQV Engineering (Commissioning, Qualification & Validation) at Körber Pharma Consulting, you will play a key role in leading your Team of CQV Consultants in planning, executing, and documenting qualification and validation activities for pharmaceutical equipment and systems. We are a highly flexible and result driven organization creating a real value for our customers. As a teamlead you take an active part in ensuring success for our customers while also managing our commercial results.
You have a hands-on mentality working closely with our clients in the pharmaceutical and biotech industries to ensure regulatory compliance and product quality.
Your role in our team
You are responsible for CQV business development activities and team management:
* Independently manage your team and the customer CQV activities from planning through to final acceptance.
* Ensure proper creation and maintenance of technical documentation (URS, design specifications, risk assessments, test plans, etc.).
* Develop and implement verification strategies in accordance with regulatory requirements (FDA, EU GMP, ICH, ASTM E2500, GAMP 5).
* Support project management tasks and coordinate with cross-functional teams.
* You support our pharmaceutical customers with design and planning of their qualification (and validation) activities in a regulated industry.
* Develop, mentor and guide your team of CQV and Senior CQV engineers to continuously improve their skills and abilites.
Your Profile
* Degree in engineering or a comparable qualification (e.g., Master Technician)
* Several years of experience in CQV or related fields within the pharmaceutical or biotech industry
* You have a demonstrated ability to interact effectively with all levels (incl. C-level) of an organization
* Proven record in leading teams in a remote setup
* Experience in managing budget and commercial responsibilty
* Solid knowledge of regulatory requirements and best practices (GMP, GAMP 5, FDA, EU GMP)
* Confident handling of technical documents such as P&IDs, electrical drawings, and certificates of conformance
* Strong communication, organizational, and problem-solving skills
* Willingness to travel regionally and internationally
* Language skills: Fluent in English and German
* Domain knowledge or experience with pharmaceutical equipment such as packaging machines, filling lines, lyophilizers, or cleanroom utilities (WFI, HVAC)
* Familiarity with higher-level systems such as ERP, MES, DCS, or historian systems
* Additional training or certifications in CQV/validation
Your Benefits
* Permanent employment contract and flexible working arrangements (remote work and flexible working hours possible)
* Our offices are located in Karlsruhe, we support working from remote / from home!
* Innovative work environment with national and international projects.
* Long-term development opportunities in a growing team.
* Flat hierarchies and a collaborative working atmosphere.
* Attractive, performance-based compensation.
* Corporate Benefits
* Karlsruhe location benefits: fitness studio, Cantina
Apply now and join our team!
Ready for your next step? Click on ‘Apply now’ to get started right away! As long as the position is advertised, you can apply at any time.
We value diversity and therefore welcome all applicants - regardless of gender, nationality, ethnic or social origin, religion/belief, disability, age, sexual orientation and identity, and any other protected status.
If you have any questions or technical problems, please send us an e-mail to jobs@koerber.com. Nele Kunkel is the responsible person for this job advertisement. We work with permanent partners and therefore ask recruitment consultants to refrain from contacting us by e-mail or telephone.