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Senior Qualification Engineer
vor 2 Monaten
Your vision is ambitious
At Exyte, we share your ambition. Our success is driven by our people, and as part of our team, you will play a crucial role in achieving engineering excellence for the advanced technology sectors of tomorrow, including pharmaceuticals, biotechnology, data centers, and more.
Discover your exciting role
Exyte stands as a global frontrunner in the design, engineering, and delivery of sophisticated pharmaceutical facilities.
As a Senior Engineer in Qualification & Validation (m/f/d), you will operate within the Bio Life Sciences sector at Exyte Central Europe, reporting directly to the Group Lead for Qualification & Validation (m/f/d). Your work will primarily involve collaborating with clients on-site to ensure the qualification of essential equipment and facilities. You will be part of a highly skilled team of qualification and validation engineers, focusing on projects mainly within Germany, with the option for mobile working based on project requirements.
Explore your tasks and responsibilities
- Manage project-specific qualification and validation activities in compliance with current GMP regulations within cleanroom environments.
- Provide GMP consulting for the planning and development of pharmaceutical facilities, including the creation and implementation of qualification strategies.
- Develop qualification and validation documentation, including test plans and reports (FAT/SAT, DQ, IQ, OQ, PQ), while executing and coordinating GxP reviews and risk assessments.
- Serve as the liaison between qualification teams, technical engineers, suppliers, and clients, ensuring effective communication and reporting to project management.
- Oversee the assessment and implementation of change and deviation management (CAPA), including tracking and monitoring CAPA activities.
Show your expertise
- You hold a degree in biotechnology, food technology, pharmaceuticals, medical technology, or a related discipline.
- You possess a minimum of 4 years of professional experience in the life sciences sector, with extensive knowledge in qualification, validation, and/or engineering of process plants, clean rooms, and media systems.
- You have a solid background in project management and are adept at applying relevant technical knowledge and current regulations.
- You are fluent in German and have good proficiency in English.
- You demonstrate a proactive approach to customer engagement and maintain a quality-oriented, independent work style.
- You are open to working on-site with clients as needed.
What we offer you
- Comprehensive onboarding: Participate in a two-day orientation event with new colleagues.
- Modern workspace: Enjoy spacious workstations equipped with height-adjustable desks.
- Buddy-System: Benefit from several weeks of close integration with your team members.
- Work-life balance: Flexibility to transition to mobile working when feasible.
- Refreshments: Access to complimentary coffee specialties and water dispensers on every floor.
- Health benefits: Exyte subsidizes your fitness membership through Qualitrain at over 5,000 locations across Germany.
Get more than just a job
Contact
Exyte is an Equal Employment Opportunity employer committed to providing equal opportunities to all qualified applicants, regardless of ancestry, gender, sexual orientation, gender identity, race, color, religion, protected veteran or disability status, or genetic information.
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