Process Engineer SME

Reposted 2 Days Ago
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Lengnau, Aargau
In-Office
Senior level
Biotech
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
The Role
The Process Engineer SME manages projects, supports validations, assures compliance with cGxP standards, and acts as a subject matter expert.
Summary Generated by Built In

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

At Thermo Fisher Scientific Inc., we provide an outstanding opportunity to be a part of world-class engineering projects that make a difference. As a Process Engineer SME, you will have the chance to work on ambitious projects that craft the future of scientific research and healthcare.

Key Responsibilities
  • Act as Project Manager for smaller modifications and improvement projects of assigned systems, including planning and project execution
  • Support ongoing and future investment projects within your field of responsibility, acting as the engineering SME and final customer
  • Coordinating cGxP-status of assigned systems, leading all aspects of initial and requalification, maintenance, and recalibration activities
  • Serve as the first point of contact for assigned systems during audits and inspections
  • Act as SME on single-use and disposable technology
  • Review and prepare GxP-relevant documents to ensure compliance
Requirements
  • Proven experience in project management and engineering within a similar role
  • Strong understanding and experience with cGxP regulations
  • Expertise in single-use and disposable technology
  • Outstanding organizational and communication skills
  • Ability to successfully implement and manage multiple projects simultaneously

Join our team and contribute to flawless execution of innovative projects. At Thermo Fisher Scientific, we strictly determine the best paths to achieve outstanding results. Your expertise and dedication will drive our success as we compete in the global market. Be part of something outstanding and collaborate with colleagues who share your passion for excellence!

Top Skills

Cgxp Regulations
Disposable Technology
Project Management Tools
Single-Use Technology
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The Company
HQ: Waltham, MA
100,000 Employees

What We Do

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Why Work With Us

You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.

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