Senior Manager - Manufacturing Engineering

Sr. Manager, Manufacturing Engineering

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.

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%)