Manager, Msat Engineering
When you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery.
With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
**Scope of role/responsibility
The MSAT Engineering Manager will lead a team responsible for end-to-end tech transfer and capex projects at the Monza Thermofisher production site.
Responsibilities of this role shall include both hands-on tactical support of ongoing plant operations and strategic implementation engineering projects to meet the changing needs of the business.
This involves startup a new commercial manufacturing process, technology transfer, and process validation.
The Process Engineering Supervisor and the Project Engineering Supervisor will report to MSAT Engineering Manager.
- Key Areas of Responsibility:
- Work with multi-functional teams to drive execution of CAPEX project/tech transfer deliverables and produce required documentation (URs, P&Id, trial protocol, etc.
)
- Lead collaborations with commercial manufacturing and quality to support ongoing qualification activities associated with maintaining a commercial product (new equipment qualifications, etc.
)
- Be an owner of commercial product(s) and be accountable for engineering-related Change Controls, Deviations, CAPAs, and Continuous Improvements
- Resolve complex commercial manufacturing issues and provide technical support of critical process-related deviations in terms of leading root cause investigations and implementation of corrective or preventative actions
- Lead all aspects of process trending of CPPs and develop/implement manufacturing solutions.
- Support site validation-related activities for the design, commissioning, qualification, and continued validation maintenance of all equipment, facilities, and utilities, including identification of opportunities for improvement
- Drive continuous improvement activities and operational excellence
- Build and lead a team of process engineering experts who will work closely together and within a highly matrixed, multi-functional team to successfully deliver business objectives
- Provide guidance and act as key stakeholder for design review, equipment specifications, performance criteria, success factors, budget management, and construction & installation oversight for specified capital projects
- Qualifications:
- Engineering Master's Degree (Chemical Engineering Preferred) with 7+ years of experience
- Prior experience in developing and/or managing engineers
- Experience with equipment design, commissioning, troubleshooting, etc for cGMP environment.
- Understanding of engineering principles for manufacturing combination drug product, and/or pharma batch processes.
- Prior experience in driving process development and implementation for commercial GMP manufacturing processes, including process qualification (IOQ, PPQ, RQ) and managing validation teams
- Strong communication (written and verbal), collaboration, and team-building skills; ability to connect with all levels of the organization
- BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Watch as our colleagues explain 5 reasons to work with us.
As one team of 100, 000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. 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.
- Accessibility/Disability Access
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