Work Schedule
Other

Environmental Conditions
Office

Job Description

When you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create meaningful contributions to the world.

Location: This position will be based at our High Point, NC facility. (Fully on-site)

Hours: Standard Day Shift

Discover Impactful Work:

The Manager of Manufacturing Engineering will be responsible for day-to-day activities of the engineering team. This role will provide technical support to internal and external customers, managing a team passionate about crafting robust processes, design, development, and implementation of new technologies.

• Leads daily operations of the Engineering team.
• Conduct analysis of existing manufacturing performance and identify areas of opportunities.
• Craft and develop new technology strategies to address the manufacturing opportunities.
• Project management of the integration and start-up of the new manufacturing technologies ensuring project is completed on time, within budget, and with the accurate user documentation.
• Assists with the development and management of related policies, procedures, and protocols to ensure consistency and efficiency. Assures that activities are conducted in compliance with US and EU regulations and EHS requirements.
• Reviews and approves documents prepared by the team. Writes protocols, assessments, change controls, and summary reports as needed.

• Ability to train and mentor others.
• Experience and interpretation of statistical process control.
• Good communication (oral and written), interpersonal and time management skills.
• Support technical activities at the plant level to ensure regulatory compliance and efficiency of facilities, equipment, and processes.
• Ability to analyze data and translate raw information so that it can be easily understood and applied by the entire site.
• Apply cGMP regulations and guidelines to all aspects of qualification activities.
• Professional knowledge and experience with gap analysis, GxP requirements, FMEA, and FDA/EMEA requirements applicable to the pharmaceutical industry.
• Experience with supervision.

• Bachelor's Degree in Engineering.
• At least 6 years of engineering experience in GMP environment (Pharma / Biopharma), and at least 1 to 2 years of management experience.
• Must meet applicable DEA security clearance requirements.

• Shown success working across organizations in highly matrixed / multi-functional environment.
• Experience in equipment design and layout using AutoCAD.

• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to write technical reports, business correspondence, protocols, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, top management, clients, customers, the general public, and/or boards of directors.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to apply mathematical operations, to such tasks as statistical analysis, geometry, calculus, and thermodynamics.
• Ability to address practical problems with a variety of variables. Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Apply engineering software such as AutoCAD, LabView, Lookout, and RSLogix.
• Ability to use a PC and the following software: Microsoft Word, Excel, and Project.

• While performing the physical duties of this job, the employee is occasionally required to stand and walk; frequently required to sit, use hands to finger, handle, or feel, and talk/hear/listen. Close vision is required.
• The employee must occasionally lift and/or move up to 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the job function.
• The employee may be occasionally exposed to moving mechanical parts, high precarious places, fumes, or airborne particles. The noise level is moderate to high.
• PPE only required when in production areas; then lab coat, safety glasses, safety shoes, and hair protection are required. Hearing protection may be required in certain areas.