Manufacturing Engineer II

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.

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. * The Project Engineer will support/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. * The Project Engineer 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 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 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 somewhat complex processes and systems.

* BS/BA degree in Chemical or Mechanical Engineering or related industry experience. * A minimum of 2 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. Specifically, steam-in-place and clean-in-place 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. * 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, mechanical aptitude, verbal communication, and interpersonal and problem solving skills. * Validation experience relative to Biopharmaceutical equipment and systems and control systems is a must.