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, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Description:
As a Sr. Manager, Manufacturing Engineering at Thermo Fisher Scientific, you will guide and support our global engineering teams to drive operational excellence and innovation across our manufacturing facilities. You will provide strategic direction and technical leadership for manufacturing processes, automation initiatives, and continuous improvement projects while ensuring compliance with quality and regulatory requirements. Working collaboratively with cross-functional teams, you'll optimize production efficiency, implement new technologies, and deliver solutions that enable our mission of making the world healthier, cleaner and safer.
How You Will Make an Impact:
Flawless launch and execution of New Product Introductions at our key sites
Manage cross functional teams ranging from Process, Packaging, Automation Engineering and Project Management
Delivery of key strategic objectives focused on productivity, quality, delivery, service, cost, innovation, and growth commitments for the Single Use Division
Responsible for monthly Engineering reviews that capture project status, deliverables and KPI's
Effective collaboration and point of contact for Product Management, Product Engineering, Finance, Supply Chain, Procurement, Business, R&D, IT, HR, Quality and Vendors across key strategic initiatives
Drive continuous process improvement, best practice, and problem-solving capabilities
Support revenue generation and margin enhancement projects across the network
A Day in the Life:
Technical Responsibilities, Knowledge, Skills, and Abilities
Process mapping and manufacturing layouts
Process and equipment specifications
Statistical process and root cause analysis
New processes for NPI (PCP core member)
Process characterization and qualification
Equipment installation and qualification; Design of Experiment (DOE), Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification, (PQ), Process Validation (PV)
Process and Design Failure Mode Effect Analysis (DFMEA/PFMEA)
Finite Element analysis (FEA)
Blank-sheet mechanical, electrical, and controls design
Major modifications to existing machinery including relocation and requalification
Web processing, coordinated motion, robotics, vision
Deploy and utilize SUD standards for equipment design and documentation
CE certification via internal and 3rd party testing
Assembly and wiring including panel-build
Component and material procurement including local and regional sourcing capabilities
Custom packaging design, qualification (ISTA 1A, 2A, 3A, 2E, 3E, 3B) including temperature and humidity environmental testing
Manage portfolio of projects, ranging from $10M-$40M CAPEX annually
Management from RFQ (initial quoting), business case, approval, initiation, development, to closure
Full management of scope, timeline, and budget
Validation and regulatory compliance activities
Risk assessments, protocol generation and horizontal deployment
Leadership Responsibilities
Coach and mentor team members including interns through effective leadership, development plans and skills matrix
Sits on approval board for change management and an active member of the manufacturing engineering group and communities of practice.
Provide strategic leadership and direction to the operational (sites) for productivity, innovation, quality, safety, and capacity requirements
Understand voice of the customer through technical collaborations, market feedback and product evolution
Key focus around emerging technologies and advancements to ensure industry leading solutions can be applied in our manufacturing environments for competitive advantage
Support key performance metrics such as Overall Equipment Efficiency (OEE), Mean Time to Repair (MTTR), Downtime, Right First Time (RFT), On Time to Promise (OTTP), On Time in Full (OTIF), Engineer to Order (ETO) and Engineer Change Order (ECO)
Utilize employee engagement surveys results to improve team dynamics, developmental needs, and enhance overall work experience.
Strong leader with critical thinking capabilities and a risk based approach
Education & Experience:
Advanced Degree plus 8 years of experience, or Bachelor's Degree plus 10 years of experience in regulated manufacturing environments (pharmaceutical, medical device, or related industries)
Preferred Fields of Study: Engineering (Mechanical, Electrical, Manufacturing, Chemical) or related technical field
Industry certifications in Six Sigma, PMP, or related areas are beneficial
8+ years of leadership experience managing technical teams and facilitating organizational change
Requirements:
Demonstrated success implementing automation, digitalization and continuous improvement initiatives
Strong understanding of cGMP, ISO standards and regulatory compliance requirements
Knowledge of new product introductions, technology transfers and process validation
Expertise in lean manufacturing principles, Six Sigma methodology and practical process improvements (PPI)
Demonstrated ability to develop and execute strategic plans aligned with business objectives
Strong project management skills and experience leading complex, cross-functional initiatives
Excellent analytical and problem-solving capabilities with data-driven decision making
Strong communication and interpersonal skills to engage stakeholders at all levels
Proficiency with manufacturing systems, automation platforms and quality tools
Ability to manage multiple priorities effectively across sites, projects and processes
Experience with capital project planning, budgeting and resource allocation
Travel required (typically 10-20%)
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.
