When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
- Process Engineer is primarily responsible for supporting manufacturing related cGMP equipment and systems. The Process Engineer is responsible for leading investigations and deviation processes to establish assignable root causes for equipment, system or process failures, as well as to establish appropriate corrective and preventive actions. The Process Engineer will ensure that all department responsibilities are performed and documented accurately, timely and in compliance with SOPs, cGMPs and FDA requirements. Maintains effective and cooperative relationships with all departments within the Grand Island site, including Feasibility, Quality, Product Management and R&D.
- Writes procedures, investigations, protocols, reports change controls, etc. to support client programs.
- This includes identifying equipment and/or processes, following equipment delivery, coordination of installation; and preparing protocols, performing testing, collecting samples, analyzing test results, and preparing summaries.
- Provide technical assessment and validation review/approval for engineering and process changes.
- As required, support/present validations to customer/regulatory authorities during routine inspections
- The incumbent will be responsible for selecting processes and provide technical assessment and validation review/approval for engineering and process changes.
- Interpreting, executing, and/or recommending modifications to site policies, encompassing all disciplines for small and large projects.
- This position will independently provide technical validation engineering support for process and/or equipment upgrades, replacements, and modifications in manufacturing and manufacturing support environments.
- Requires the ability to troubleshoot systemic issues, develop, organize, analyze, and present interpretation of results regarding operational issues or projects, and apply advanced engineering principles to the design and implementation of new or modified systems or processes.
- Requires working knowledge of engineering principles and practices that can be applied to a broad variety of assignments in related fields, the ability to develop and apply creative technical solutions to complex problems, and working with manufacturing, process development, engineering, analytical, and quality assurance staff to develop requirements and recommendations for large and somewhat complex processes and systems.
Education and Industry Experience
· Bachelor’s degree in Chemical, Mechanical, Electrical Engineering or related discipline. 5+ years of process engineering and/or project management experience, preferably in a pharmaceutical or biotechnology environment.
· Must be able to work independently, organize and manage projects by demonstrating progress against defined milestones, budgets and schedules.
· Must have a thorough knowledge of manufacturing processes, quality systems, engineering fundamentals, regulatory agency expectations and industry trends.
· Experience with regulated environments (i.e. cGMP, FDA, ISO 13485, OSHA, EPA) is preferred.
· Candidates should demonstrate an in-depth knowledge of validation processes and programs, familiarity with pharmaceutical/biotech processes, and familiarity with documentation in a highly regulated environment.
· Additional requirements include the ability to operate specialized laboratory equipment and computers, interpret and apply, GLP’s and GMP’s, as well as the ability to apply validation engineering to production, and develop solutions to routine technical problems of varying complexity and scope.
Requires strong technical writing, verbal communication, and interpersonal and problem solving skills.
At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com