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Senior Qualification Engineer
vor 3 Monaten
Your vision is ambitious
At Exyte, we share your ambition. Our people are the cornerstone of our success. By joining us, you will play a pivotal role in driving engineering excellence across high-tech sectors, including semiconductors, pharmaceuticals, biotechnology, and data centers. Become part of a global community of innovators who are passionate about shaping the future.
Discover your exciting role
Exyte stands as a global leader in the design, engineering, and execution of intricate pharmaceutical facilities.
As a Senior Engineer in Qualification & Validation (m/f/d), you will be integral to our Bio Life Sciences division at Exyte Central Europe, reporting directly to the Group Lead for Qualification & Validation (m/f/d). Your role will involve collaborating closely 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, primarily focusing on projects within Germany, with the option for mobile working depending 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, along with 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, while reporting to project management.
- Oversee the assessment and execution of change and deviation management (CAPA), including tracking and monitoring of CAPA activities.
Show your expertise
- You hold a degree in biotechnology, food technology, pharmaceutical technology, medical technology, or a related discipline.
- You possess a minimum of 4 years of professional experience in the life sciences sector, with in-depth knowledge of qualification and validation processes, as well as engineering and commissioning of process plants, clean rooms, and media systems.
- You have a solid background in project management and are well-versed in applying relevant technical knowledge and current regulations.
- You are fluent in German and have proficient English language skills.
- You demonstrate a proactive approach to customer engagement and possess a quality-oriented, independent work ethic.
- You are open to working on-site with clients as required.
What we offer you
- A comprehensive onboarding experience, including a two-day event with new colleagues.
- A modern workspace featuring spacious workstations with adjustable desks.
- A Buddy-System for several weeks of close integration with your team.
- Flexible work-life balance with options for mobile working.
- Complimentary coffee specialties and water dispensers available on every floor.
- Fitness benefits 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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