Thermo Fisher Scientific Manager, Manufacturing Engineering in Fremont, California
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
How will you make an impact?
Thermo Fisher Scientific's Clinical Diagnostics Center of Excellence in Fremont, CA is looking for a highly motivated and talented Manager to lead the Manufacturing Engineering and Validation teams. The Manager, Manufacturing Engineering will ensure programs to continuously drive improvements in safety, quality, and productivity are completed as scheduled and are in compliance with current regulatory agency standards.
What will you do:
Manage the team of engineers to execute capital projects in support of a cGMP manufacturing facility. Includes involvement throughout the project life cycle including project scope, option analysis, engineering design, execution, qualification and validation.
Ability to work independently or lead Manufacturing Engineering and Validation Supervisors and a team of engineers with design and implementation of larger projects.
Provide process engineering technical support of manufacturing equipment and utilities.
Leads system and equipment design and procurement. Draft engineering documentation such as PFDs, ROI's, P&ID's, URS's, Design Specifications, RFQs, contractor bid packages, equipment data sheets, and validation (I,O,P/Q) documents.
Properly scoping capital projects and adhering to project timeline and completion.
Partners with internal and external customers to execute projects on time.
Identify and implement improved processes, new equipment and operational continuous improvement opportunities.
Identify automation and equipment to improve efficiency and throughput in a compliant environment.
Represent Manufacturing Engineering in product transfer projects.
Provide technical training to manufacturing operations staff of processes, equipment, utilities, automation and operational changes.
Clearly communicate with Manufacturing, Technical Operations, Facilities, and Quality staff at various levels to drive efficient issue resolution and change implementation.
Develop and engage the engineering team and manage individual performance.
Stays current with all applicable QSR and ISO regulatory requirements as well as industry standards.
Use data statistics and SPC to ensure operational processes are in control.
Minimum 6 years of related experience within a compliant manufacturing environment.
A Bachelor's Degree in Engineering, Chemistry, Biology or life sciences discipline required.
Previous Engineering or Validation experience within a compliant manufacturing environment.
Project management experience and demonstrated experience executing projects on schedule and within budget.
Strong technical leadership and supervisory experience.
Thorough understanding of current Good Manufacturing Practices (cGMPs) as they apply to manufacturing facilities.
Experience creating and executing IQ/OQ/PQ validations in a compliant environment.
Experience using risk management systems and industry standard terminology.
Proven experience scoping and executing capital projects in a compliant environment.
LEAN or Six Sigma training, certification and proven use in a compliant environment.
Strong proficiency in engineering principles and techniques, and demonstrated ability in successfully applying that knowledge.
Excellent communication and interpersonal skills.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.