Engineer II, Manufacturing Engineering
Thermo Fisher Scientific

Job Description

Engineer II, Manufacturing Engineering

Job Description

Position: Process Engineer

Location: Greenville, NC

Company information

As part of the Thermo Fisher Scientific team, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer! We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Business information

The Greenville, North Carolina, USA site is a large, multipurpose pharmaceutical development, manufacturing, and packaging campus. The operation provides both development and commercial services for sterile injectables and oral solid dose forms.

Position summary

Provide technical and process engineering expertise that provides direct support to Operations, Tech Transfer activities for new products, and strategic Capital Projects. Ensures the site operates in compliance with regulatory standards that ensures product quality, avoids stoppages, and reinforces customer satisfaction.

Key Responsibilities:

• Work with a talented 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, execute design of new equipment, and oversee 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 Execute Engineering study documents, testing, and data summaries assigned.
• Performs other duties as assigned.

Qualifications:

• Bachelor's degree in Engineering or related field is required preferably (Mechanical, Chemical, Industrial or Electrical Engineering) with a minimum of 0-2 years of relevant experience.
• Equivalent combinations of education, training, and relevant work experience may be considered.
• Effective verbal and written communication skills (legible writing)
• Effective time management and prioritization skills.
• Outstanding attention to detail and organizational skills.
• Self-starter, mature, independent and dependable.
• Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented.
• Ability to respond disciplined and rationally under pressure.
• Requires discretion and independent judgment.
• Excellent interpersonal skills to establish and maintain effective working relationships with internal engineers.
• Multiple computer skills including working experience with MS Office applications such as Word and Excel necessary.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle complex scientific challenges, drive technological innovation and support patients in need! #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

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