The Manufacturing Engineer I is responsible for supporting and leading operations projects, improving productivity and yield, as well as providing training and leadership to other technicians. In certain cases they will be asked to support Manufacturing operations by utilizing Quality System and process documentation in the production of finished goods, in a cGMP environment.
Key Objectives of the role:
Assists in the designs, evaluation, implementation, and maintenance of production equipment, processes and standards to ensure product quality and compliance with regulatory requirements.
- Works with members of the conversion team to create and/or modify a variety of methods, procedures, and work instructions to ensure that appropriate processes are developed, tests are conducted, and that products, materials, and manufacturing equipment meet required standards.
- Performs elementary statistical analysis to analyze trends, and works with the conversion team to investigate trends, conduct root cause analysis and recommend and implement corrective actions for processes.
- Assures compliance to in-house and/or external specifications to standards, such as cGMPs and ISO regulations.
- Address and resolve basic conversion related issues using real time engineering, quality, and lean principles and techniques.
- Interfaces and collaborates with other departments to coordinate process development and improvement.
- Generates and communicates technical documents, procedures, standards and guidelines
- Occasionally calibrate/operate semi-automated and automated manufacturing equipment.
- Execute on the job training of other team members as required.
- Coach others on procedures, team work, etc., and lead by example, exemplify positive behavior.
- Assign resources when and where necessary to ensure production schedule is attained.
- Identify opportunities and implement productivity improvements.
- Maintain equipment and rooms in proper operational condition
- Maintain records to comply with regulatory requirements, GMP’s and standard operating procedures.
- Monitor and ensure all personnel are following safe practices and SOP’s.
- Develop and maintain proficiency in all value stream related manufacturing departments
- Perform activities in controlled environment up to and including classified clean room conditions.
- Perform in-process testing to assure batches meet specification.
- Perform manufacture of cell culture products in accordance to current good manufacturing practices.
- Support and initiate quality, safety, compliance improvement initiatives.
- Comply with all company safety regulations and procedures.
- May be required to perform other related duties as required and/or assigned
Nature and Scope:
Works on assignments that are complex in nature where judgment is required in resolving problems and making routine recommendations. Normally receives no instruction on routine work and minimal instruction on new assignments. May determine methods and procedures on new assignments and may lead other non-exempt personnel.
Bachelor’s degree in Biology, Chemistry, Engineering, or equivalent knowledge and experience is required.
Entry level Engineering position with no direct experience required.
Demonstrated manufacturing environment experience and leadership capabilities are preferred.
Knowledge of computer applications and current software is desirable.
General understanding of machinery and mechanics.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
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