Engineer III, Manufacturing Engineering

$83,300 - $115,000/Yr

Thermo Fisher Scientific - Grand Island, NY

Full-time - Mid Level

Grand Island, NY

Computer and Electronic Product Manufacturing

About the position

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. The Engineer III in Manufacturing Engineering will support manufacturing-related cGMP equipment and systems. This role assumes responsibility for leading investigations and deviations processes to establish root causes for equipment, system, or process failures, as well as establish appropriate solutions. The Engineer ensures all department responsibilities are performed and documented accurately, timely, and in compliance with SOPs, cGMP, and FDA requirements. In this position, you will support manufacturing by identifying equipment and/or processes, preparing protocols, performing testing, collecting samples, analyzing test results, and preparing summaries. You will generate and complete technical assessments and validation review/approval for engineering and process changes, and manufacturing instructions. Additionally, you will interpret, implement, and/or recommend modifications to site policies, encompassing all fields for small and large projects. Addressing systemic issues will be a key part of your role, as you will develop, coordinate, analyze, and present corrective and preventative actions regarding operational issues or projects, applying engineering principles to the design and implementation of new or modified systems or processes. You will also support qualifications (IQ/OQ/PQ) across engineering, manufacturing, facilities, maintenance, quality, and other functional partners to complete projects in support of manufacturing. Accepting Practical Process Improvements (PPI) through identifying and implementing changes will be part of your responsibilities. This position requires 24/7 call support for manufacturing issues/deviations, ensuring that you are always ready to address any challenges that arise.

Responsibilities

• Support manufacturing through identifying equipment and/or processes, preparing protocols, performing testing, collecting samples, analyzing test results, and preparing summaries.
• Generate and complete technical assessments and validation review/approval for engineering and process changes, and manufacturing instructions.
• Interpret, implement, and/or recommend modifications to site policies for small and large projects.
• Address systemic issues, develop, coordinate, analyze, and present corrective and preventative actions regarding operational issues or projects.
• Apply engineering principles to the design and implementation of new or modified systems or processes.
• Support qualifications (IQ/OQ/PQ) across engineering, manufacturing, facilities, maintenance, quality and other functional partners to complete projects in support of manufacturing.
• Accept Practical Process Improvements (PPI) through identifying and implementing changes.
• Provide 24/7 call support for manufacturing issues/deviations.

Requirements

• Bachelor's Degree in Chemical, Biomedical, Mechanical, or related Engineering or Scientific Degree.
• 6 - 9 years experience working in a manufacturing environment or related technical fast-paced, impactful environment.
• Detailed knowledge of manufacturing processes, quality systems, engineering fundamentals, regulatory agency expectations and industry trends.
• Experience with regulated environments (i.e. cGMP, FDA, ISO 13485, OSHA, EPA), preferred.
• Strong technical writing, verbal communication, and interpersonal and problem-solving skills.

Nice-to-haves

• Experience with regulated environments (i.e. cGMP, FDA, ISO 13485, OSHA, EPA), preferred.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan.
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.