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
Thermo Fisher Scientific is a biotechnology product development company located in Waltham, MA. The company's premier brands are Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services. Generating more than $24 billion in annual revenue, Thermo Fisher Scientific is a significant player in the research, healthcare, industrial and applied markets, with a range of customer touch points that is hard to match.
Position Summary
This position is under the direction of the Sr Engineering Manager and includes responsibilities involving the direct supervision of engineers and technicians. This position will also be responsible for leading projects aimed at designing, implementing and documenting engineering activities as well as to develop and drive continuous improvement processes. The role also employs engineering and scientific principles to drive engineering problems and improvements to fundamental understanding and implement efficient solutions.
Key Responsibilities:
Lead a team of 3-7 engineers and technicians, this role is both a leader/supervisor and direct contributor
Engage as an active supervisor as a coach/mentor for staff by developing and empowering employees; cultivating relationships and ensuring project success
Attract, hire and retain talent by fostering an exciting workplace
Build effective teams by ensuring work is well defined, mapped out, provide clear results and due dates
Measure, track and report on project progress
Remove roadblocks for employees to ensure personal and business success
Work to understand employees career plans and partner with them to ensure they are on their trajectory to success
Foster a work culture that brings out the best in people while at the same time enabling the success of the company
Lead projects and people aimed at excellence in safety, quality, and delivery of the engineering initiatives
Develop project plans against business objectives, work multi-functionally to ensure results are clear and well-defined, exercise business sense across the site to ensure project targets are met or exceeded
Drive projects to closure; track timelines and remove roadblocks encountered by the team
Mentor and coach junior engineers and technicians
Follow all safety and current Good Manufacturing (cGMP) requirements within the plant
Develop User Requirement Specifications (URS)
Develop and complete Field Acceptance Testing (FAT) and Site Acceptance Testing (SAT) using User Requirement Specifications (URS)
Support validation engineering activities including Installation Qualification (IQ), Operational Qualification (OQ), Process Validation (PV), and Performance Qualification (PQ) activities
Create, implement, and document all equipment and processes within the plant-based system
Apply statistical methods when appropriate ranging from Design of Experiments (DOE), T-tests, ANOVA, Gage R&R, and others, to optimize critical process parameters of manufacturing systems
Minimum Qualifications:
Bachelor's degree in Engineering, Statistics, Technical or related field (Master's preferred)
Proven track record with 5+ years of process engineering leadership experience in biopharma, medical device, food processing or related manufacturing environment
5+ years of experience in project leadership, project management, program strategy, scope & resource definition, possibility/solution work stream generation, knowledge management, and its transition to applications
Project leadership experience
Ability to lead people as direct supervisor or in a matrix environment; coaching and mentorship skills
Ability to switch rapidly between supervision and direct contributor roles
Experience with engineering in a regulated environment
Standards knowledge including ISO9001 and ISO13485
Proficient in MS Office
Ability to create detailed timelines (i.e. MS Project or similar), lead project teams, host team meetings, measure and track the project progress and ensure success
Effective communication skills both written and verbal
Positive, can-do approach with ability to work independently and as a member of a multi-functional team; team-player
Ability to work in fast-paced results orientated environment
Desire to contribute to the business and its team
Highly organized and self-motivated
Very hands-on work ethic
Ability to work flexible hours if needed
At Thermo Fisher Scientific, each one of our 125,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
