Manager, Manufacturing Engineering

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 significant contributions to the world.

Location/Division Specific Information

This position will be based at our High Point, NC facility.

Discover Impactful Work:

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

A day in the Life:

• Supervises daily operations of the Engineering team.
• Conduct analysis of existing manufacturing performance and identify areas of opportunities.
• Design 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 proper technical 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.

Keys to Success:

• Ability to train, mentor, and coach others.
• Experience and interpretation of statistical process control
• Good communication (oral and written), organizational 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 utilized 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.

Education

• Bachelor's Degree in Engineering.

Experience

• At least 6 years of engineering experience in GMP environment (Pharma / Biopharma), prefer at least 1 to 2 years of management experience.
• Shown success working across organizations in highly matrixed / team environment.
• Experience in equipment design and layout using AutoCAD.

Language skills:

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.

Mathematical skills:

Ability to apply mathematical operations, to such tasks as statistical analysis, geometry, calculus, and thermodynamics.

Reasoning ability:

Ability to solve practical problems and deal with a variety of variables. Ability to define problems, collect data, establish facts, and draw valid conclusions.

Other skills and abilities:

Ability to use engineering software such as AutoCAD, LabView, Lookout, and RSLogix.

Ability to use a PC and the following software: Microsoft Word, Excel, Project, and PowerPoint.

Certificates, licenses, registrations

None required.

Special requirements

Must meet applicable DEA security clearance requirements.

Physical demands

While performing the physical duties of this job, the employee is occasionally required to stand and walk. The employee is frequently required to sit, use hands to finger, handle, or feel, and talk/hear/listen to (connect with others). 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.

Work environment

The employee may be occasionally exposed to moving mechanical parts, high precarious places, fumes or airborne particles. The noise level is moderate to high.

Personal protective equipment

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.

Benefits

We offer competitive 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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.