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.
The Manufacturing Engineer I is responsible for supporting and leading operations projects, improving productivity and yield, upgrading manufacturing equipment and processes, leading investigations and providing training for technicians. In certain cases they may 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 design, evaluation, implementation, and validation of production equipment, processes and standards to ensure product quality and compliance with regulatory requirements.
- Perform selection and validation of equipment, automation systems, and processes for the manufacturing operations.
- Support and initiate quality, safety and compliance improvement projects.
- Works with other team members 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.
- Perform validations and qualifications of new processes and equipment prior to use.
- Assures compliance to regulatory 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.
- Monitor and ensure all personnel are following safe practices and SOP’s.
- Develop and maintain proficiency in value stream related manufacturing departments.
- May be required to perform other related duties as required and/or assigned.
Nature and Scope:
Works on assignments, projects and investigations that are complex in nature where judgment is required in resolving problems and making routine recommendations.
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.
Must be able to work independently, organize and manage projects by demonstrating progress against defined milestones, budgets and schedules; prepare regulatory summaries and present validation to regulatory authorities.
Requires strong technical writing, mechanical aptitude, verbal communication, and interpersonal and problem solving skills.
Has contact with Site Leadership Team, Engineering, manufacturing team members, direct supervisor and various levels of internal customers. May have contact with external customers and suppliers.
Works mainly in a manufacturing environment; is required to lift up to 45 lbs. and may be required to stand for long periods of time while performing duties. Must be able to work safely