Engineer II, Manufacturing Engineering - Thermo Fisher Scientific : Job Details

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, OfficeJob DescriptionJoin 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 InformationThe 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.Discover Impactful Work:The Engineer III, Manufacturing Engineering (Process Engineer) role presents an outstanding opportunity to be at the forefront of capital engineering projects and start up of new equipment and supporting existing commercial operations equipment. You will be included in an ambitious environment where your contributions will directly impact the success of various high-impact projects and producing life saving products for patients. With proven methodologies and a collaborative team, you'll play a key role in successfully implementing solutions that compete on a global scale.A day in the Life:

• 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.

Education

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

Experience

• 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.

Knowledge, Skills, Abilities

• 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.

BenefitsWe offer driven remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!Apply today! 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.Accessibility/Disability AccessThermo Fisher Scientific provides accessibility services for job seekers with disabilities. This includes assistance for hearing, vision, mobility, or cognitive impairments. If you need an accommodation to apply for a job, please contact us at 1-855-###-####*.If you have a disability and need assistance or accommodation during the job application process, please call this telephone line. We do not respond to messages about non-disability related technical issues or other purposes.