Thermo Fisher Scientific is a biotechnology product development company located in Waltham, MA. The main brands of the company 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 leading player in research, healthcare, industrial and applied markets, with a range of customer touchpoints that are hard to match. The company offers diverse career opportunities at more than 600 locations across the Americas, APAC and EMEA regions in a global and inclusive culture that values the diversity of talent. With the main activity being scientific R&D, there are also opportunities in operations, quality and regulation, IT, sales and more. As an employee, you can count on numerous opportunities to develop your career as well as a comprehensive set of rewards which include competitive base salary, medical and dental plans, wellness programs, insurance paid by business, savings and expense accounts, a 401 (k) and more.
When you join us at Thermo Fisher Scientific, you’ll be part of an intelligent and driven team that shares your passion for exploration and discovery. With revenues of $ 22 billion and the industry’s largest R&D investment, we empower our people with the resources and opportunities to make a meaningful contribution to the world.
Summary of position
This position reports to the Director of Process Engineering and includes responsibilities involving the direct supervision of engineers and technicians. This position will also be responsible for leading projects aimed at designing, executing and documenting validation engineering activities as well as developing and piloting continuous improvement processes. The role also uses engineering and scientific rigor to bring process engineering problems to a fundamental understanding.
- Lead a team of 5 to 7 engineers and technicians
- Engage as an active supervisor as a coach / mentor for staff by developing and empowering employees; cultivate relationships and ensure the success of the project
- Attract, hire and retain talent by fostering a stimulating work environment
- Build effective teams by ensuring that work is well defined, mapped and clear
- Remove barriers for employees to ensure their personal and professional success
- Work to understand employee career plans and collaborate with them to ensure they are on the path to success
- Foster a work culture that brings out the best in people while enabling business success
- Lead projects and people aiming for excellence in safety, quality, process engineering and validation initiatives
- Develop project plans against business goals, work cross-functionally to ensure deliverables are clear and well-defined, exercise business acumen across the site to ensure project milestones are met and overwhelmed
- Drive projects to closure; track deadlines and remove obstacles encountered by the team
- Supervise and coach junior engineers and technicians
- Follow all current Safety and Good Manufacturing (cGMP) requirements within the factory
- Develop and execute Field Acceptance Tests (FAT) and Site Acceptance Tests (SAT) using User Requirements Specifications (URS)
- Lead validation engineering activities, including installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) activities
- Create, execute and document all validation activities within the plant based system
- Use design of experiments (DOE) to optimize critical process parameters of manufacturing systems
- Bachelor’s degree in engineering, statistics, technical or related field (master’s degree preferred)
- Previous experience in supervision, coaching, mentoring, assignments, etc.
- Project management experience
- Ability to lead people as a direct supervisor or in a matrix environment; coaching and mentoring skills
- Experience in validation engineering in a regulated environment
- Knowledge of standards including ISO9001 and ISO13485
- Proficient in MS Office
- Ability to create detailed timelines (i.e. MS Project or similar), lead project teams, organize team meetings and ensure project success
- Excellent technical aptitude
- Effective written and verbal communication skills
- Positive and dynamic attitude with the ability to work independently and as part of a cross-functional team; team player
- Ability to work in a fast-paced, results-oriented environment
- Desire to contribute to the company and its team
- Very organized and motivated
- Very practical work ethic
- Ability to work flexible hours when required
- Mechanical engineering skills (Solidworks, AutoCAD)
- Skills in statistical engineering (ANOVA, DOE, parametric, non-parametric, SPC, etc.) and software platforms (Minitab, JMP)
- Six-Sigma knowledge / certification
- At Thermo Fisher Scientific, each of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our unique mission: to empower our customers to make the world healthier, cleaner and safer.