Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job Description

Join Thermo Fisher Scientific and contribute to impactful work while experiencing continuous growth and learning in an empowering culture. With over $40 billion in revenues and extensive R&D investment, we offer chances to create important contributions.

Location/Division Specific Information

The Greenville, North Carolina, USA site specializes in advanced manufacturing and engineering solutions with a focus on crafting world-class products. This location is world-class for its new way of thinking and its dedication to outstanding quality and precision.

• Work with a dedicated group of people to provide innovative solutions for our internal and external clients.
• Support the site CAPEX team with working with vendors to design and implement new manufacturing equipment for a Steriles manufacturing facility.
• Understand how new and existing manufacturing equipment interacts with the surrounding facility, rooms, and utilities.
• Work with the Operations, Maintenance, Project Engineering, Automation, Validation, and Quality teams as needed to complete projects.
• Work with equipment vendors to write User Requirements Specifications documents, complete design of new equipment, and be responsible for the installation of the equipment through Factory Acceptance Testing, Site Acceptance Testing, Commissioning, and Start Up of the equipment.
• Support the Operations team to help ensure Steriles manufacturing lines run efficiently and own any equipment upgrades that need to be designed and installed to improve line efficiencies.
• Understand the current Steriles manufacturing equipment regulatory design requirements and processes and ensure that existing equipment upgrades are identified and implemented as needed to keep up with current regulatory expectations.
• Support new product Tech Transfer activities for new products on existing commercial lines by working with equipment vendors as needed to ensure parts or other items are ordered, received, and tested to be able to run components for the new products.
• Perform and own any change control records associated with Process Engineering led equipment upgrades and modifications.
• Ensure familiarity with industry equipment design and compliance standards.
• Draft and Complete Engineering study documents, testing, and data summaries assigned.
• Cross-train with other Process Engineers to expand knowledge and support capability to different systems in existing area or systems in different areas. Able to lead as SME in areas of experience and knowledge.
• Performs other duties as assigned.

• Bachelor's degree or equivalent experience in Engineering or related field.

• 1 to 2 years of relevant experience is preferred. Experience as a co-op or internship can also be applied as relevant experience.
• Equivalent combinations of education, training, and relevant work experience may be considered
• Preference for Pharmaceutical or Aseptic filling industries.

• Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical cGMP.
• Proficient with computer software packages, including Microsoft Windows-based applications (e.g. Word, Excel, Project, Internet Explorer, etc.) as these packages are used routinely.
• Highly effective verbal and written communication skills.
• Must have the ability to travel to equipment vendors both domestically and internationally as needed to assist FAT testing at vendor sites for new steriles manufacturing equipment. No more than 10% of travel.
• Technical writing skills to be able to draft documents that describe how to design and operate complex equipment.