Job Title: Manufacturing Engineer III
Requisition ID: 40856BR
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.
- Perform selection and validation of equipment, automation systems, and processes for the manufacturing operations.
- 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.
- This position will coordinate the activities of Engineering, Manufacturing, Quality, and other Company groups required to complete assigned equipment projects in support of the operation of the manufacturing facility.
- The Manufacturing Engineer III will support and represent the department on the various teams (design, construction, start-up and commissioning) and will contribute directly to the completion of assignments.
- Support/manage the activities of assigned junior and contract personnel and ensure the quality of completed work.
- Provide technical assessment and validation review/approval for engineering and process changes.
- Review and approve data tables generated by peers and contract personnel.
- As required, support/present validations to customer/regulatory authorities during routine inspections.
- Investigate and close Problem Reports (PRs) and Non-Conformance Reports (NCRs) in a timely and effective manner. Implement Corrective and Preventive Action (CAPA) as appropriate.
- Utilize Lean Manufacturing Tools such as Root Cause Analysis, Gemba and Poka-Yoke to continually improve manufacturing operations
- The Manufacturing Engineer III will manage and/or apply extensive technical selection and validation engineering expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, and alteration of processes, systems or equipment.
- The incumbent will be responsible for selecting equipment and processes and establishing validation engineering policies for a major segment of the company, interpreting, executing and/or recommending modifications to company-wide policies, encompassing all disciplines for large or complex projects.
- Specific responsibilities include applying advanced technical principles, theories, and concepts in the development of new principles and concepts, performing work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept, and conceiving plans and conducting engineering research/investigation in areas of considerable scope and complexity.
- This position will independently provide and direct 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 validation issues, develop, organize, analyze, and present interpretation of results regarding operational issues or validation projects, and apply advanced validation engineering principles to the design and implementation of new or modified system or processes.
- Requires working knowledge of validation 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 validation requirements and recommendations for large and/or highly complex processes and systems.
- BS/BA degree in Chemical or Mechanical Engineering or related industry experience.
- A minimum of 10 years of equipment selection experience in a cGMP environment with increasing levels of responsibility for a wide range of projects, including design, validation, and operation of large scale biochemical manufacturing, utility and automation systems.
- Must be able to work independently, organize and manage projects by demonstrating progress against defined milestones, budgets and schedules; prepare regulatory summaries and present validation to regulatory authorities.
- Must have a thorough knowledge of validation principles, manufacturing processes, quality systems, engineering design and start-up fundamentals, regulatory agency expectations and industry trends.
- Experience with regulated environments (i.e. cGMP, FDA, ISO 13485, OSHA, EPA) is essential.
- 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.
- Ability to apply validation engineering to production and develop solutions to routine technical problems of varying complexity and scope.
- Requires strong technical writing, mechanical aptitude, verbal communication, and interpersonal and problem solving skills.
- Validation experience relative to Biopharmaceutical equipment and systems and control systems is a must.
The position may require travel (up to 20%) during the duration of projects for vendor/contactor meeting and FAT execution.
This position has not been approved for Relocation Assistance.
At Thermo Fisher Scientific, each one of our 50,000 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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.