Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Location/Division Specific Information
Thermo Fisher Scientific run's the World's largest clinical packaging operation. Our Clinical Trials facilities are strategically placed around the world to accommodate local and regional sourcing needs. Join us to help serve millions of our global clinical trials patients!
How will you make an impact?
The Engineering Manager leads all aspects of the daily operations of a team responsible for handling equipment used in processing clinical products through primary and secondary packaging operations. The Manager of Engineering will have strong attention to details and who can partner with department and functional leaders to maintain an in depth understanding of business process, drive improvement outcomes, and ensure alignment with site goals.
What will you do?
Demonstrates and promotes the company vision through Thermo Fisher's 4 I's - Intensity, Integrity, Innovation, and Involvement.
Coordinates daily and long-term business requirements and ensure equipment is in a state of readiness to meet required output.
Responsible for the creation and implementation of change controls and Standard Operating Procedures (SOPs) for operation equipment.
Responsible for ensuring training and maintaining the engineering quality system.
Responsible for product quality standards and SQIPP (Safety, Quality, Identity, Potency, and Purity) of the product and ensuring quality guidelines and timelines are met.
Handles technical and cost proposals for site equipment CAPEX and other improvement projects. Serve as Project Manager for engineering and CAPEX projects.
Provide adequate risk management and life-cycle reliability of Equipment
Prepare and handles engineering budgets and track financials for projects/budget, report status. Prepare and or review purchase requests.
Other duties may be assigned to meet business needs.
Education:
Bachelor's Degree from an accredited College or University as an Engineering Discipline is required.
5 years' of related experience working as an Engineer is required.
Prior experience leading a team of Engineers is preferred.
Knowledge, Skills, Abilities
Automation and Manufacturing Operations experience is strongly desired.
Knowledge of Manufacturing Quality systems and standards
Attention to detail and ability to identify, troubleshoot, and remediate issues found during testing.
Highly effective verbal and written skills, including technical authorship.
Sound eye for business strategy for both short and long term goals
