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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
DESCRIPTION:
Lead a team of manufacturing engineers and technical specialists in delivering excellence across our manufacturing operations. As a Manufacturing Engineering Supervisor at Thermo Fisher Scientific, you'll implement continuous improvement initiatives, oversee technical projects, and ensure efficient production of high-quality products that enable our customers to make the world healthier, cleaner and safer. Collaborate with R&D, Production, Quality, and other teams to optimize processes, implement new technologies, and solve technical challenges. Support and develop your team while fostering an environment of innovation, safety and operational excellence.
REQUIREMENTS:
Key Responsibilities
Leadership & Team Management
Supervise, mentor, and develop a team of manufacturing engineers and technicians
Assign priorities, manage workloads, and ensure timely project execution
Foster a culture of safety, quality, and continuous improvement
Process & Production Support
Oversee manufacturing processes for single-use systems (SUS), ensuring consistency and compliance
Provide technical support for daily production issues, including troubleshooting and root cause analysis
Collaborate with production, quality, and supply chain teams to meet output targets
Process Improvement & Optimization
Lead Lean, Six Sigma, and continuous improvement initiatives
Identify opportunities to improve yield, reduce waste, and optimize cycle times
Implement process validation and standardization efforts
New Product Introduction (NPI)
Support transfer of new single-use products from R&D to manufacturing
Develop and validate manufacturing processes, including equipment and tooling
Ensure smooth scale-up and commercialization
Compliance & Quality
Ensure adherence to GMP, ISO, and regulatory requirements
Support audits (internal/external) and implement corrective/preventive actions (CAPA)
Maintain proper documentation (SOPs, work instructions, validation protocols)
Ability to analyze technical data and make data-based decisions
Project Management:
Lead or support cross-functional projects related to capacity expansion, automation, and technology upgrades
Track KPIs and report on engineering performance metrics
Qualifications
Education
Bachelor’s degree in Mechanical Engineering, Electrical, Chemical Engineering, Industrial, Manufacturing, or Biomedical Engineering, or related field
Master’s degree (beneficial)
Advanced Degree plus 3 to 5 years of experience, or Bachelor's Degree plus 5 years of experience in manufacturing/engineering in regulated industry (pharmaceutical, medical device, or similar high-tech manufacturing)
Professional engineering certifications beneficial
Experience
5–8+ years of manufacturing engineering experience, preferably in biopharma or medical devices
3+ years of leadership or supervisory experience
Demonstrated expertise in manufacturing processes, equipment, and quality systems
Experience with single-use technologies (bioprocess bags, assemblies, filtration systems) strongly preferred
Demonstrated ability to develop and support technical staff
Skills & Competencies
Strong knowledge of single-use manufacturing processes (welding, sealing, assembly, cleanroom operations)
Familiarity with GMP, FDA, and ISO standards
Experience with Lean Manufacturing / Six Sigma methodologies
Excellent problem-solving, root cause analysis skills and systematic approach to issue resolution
Strong communication and cross-functional collaboration abilities
Project management and organizational skills
Collaborative leadership style with ability to work effectively across functions
Excellent verbal and written communication skills
Proficiency with CAD, CMMS, ERP systems and standard business software
Knowledge of equipment regulations and certifications (CE/UKCA)
Preferred Qualifications
Six Sigma Green Belt or Black Belt certification
Experience with automation and digital manufacturing tools
Knowledge of validation (IQ/OQ/PQ) and risk management (FMEA)
Work Environment
Combination of office and manufacturing floor (cleanroom environment)
Require PPE and adherence to controlled environment protocols
Available for travel and flexible hours as needed
