**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** **GENERAL:** The Maintenance Engineer will be responsible for all aspects of set-up activities for production equipment and tooling, including supervision of engineering technicians, set-up assistants as well as on hand solving of process equipment activities, driving preventive maintenance and performing unscheduled maintenance activities in production or facilities equipment. **POSITION DETAILS / REQUIREMENTS AND RESPONSIBILITES:** Supervises engineering technicians & set-up assistants to set priorities as well as to ensure compliance with company policies. Performs performance evaluations as needed. - Creates and implements (as the need arises) the set-up and change over plans of production process equipment. - Performs unscheduled facility and equipment maintenance in a timely manner. - Orders replacement and spare parts as needed. Follows up to ensure delivery. - Performs preventative maintenance adhering to schedule. - Make or repair tools as the need arises. - Performs or supports Calibration program according to required schedule. - Supports facility pest control and environmental monitoring program. - Supports and maintains the safety and hygiene program by ensuring compliance with all applicable government agencies. - Participates on CAPA investigation and root cause analysis for all related equipment and process related activities. - Routinely reports progress, activity status, and makes recommendations for improvement. - Aligns with all quality system requirements for ISO 13485 and FDA GMP regulations. - Works in a team environment, accomplishing any other duties as required by the company. - Responsibility for continuous education by attending seminars, workshops and courses. **EDUCATION / EXPERIENCE REQUIREMENTS:** - Bachelor of Science Degree in Mechanical or Electrical Engineering. - 2-5 years of experience in maintenance or engineering. - Bilingual English/Spanish. **PERFORMANCE OBJECTIVES:** _-_ Successful completion of ISO 13485 Audits. - Timely CAPA closure. - Equipment downtime and timely delivery to customers. - Production plan alignment and efficiency. 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.