Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionAs 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.How will you make an impact?The candidate will support manufacturing related cGMP equipment and systems. The Manufacturing Engineer 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 documents accurately, timely and in compliance with SOPs, cGMP and FDA requirements.A Day in the Life:
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, encompassing all fields for small and large projects.
Address systemic issues, develop, coordinate, analyze, and present corrective and preventative actions regarding operational issues or projects, and apply engineering principles to the design and implementation of new or modified systems or processes.
Supports qualifications (IQ/OQ/PQ) across engineering, manufacturing, facilities, maintenance, quality and other functional partners to complete projects in support of manufacturing.
Accepts Practical Process Improvements (PPI) through identifying and implementing changes.
24/7 Call support for manufacturing issues/deviations
Keys to Success:Education
Bachelor's Degree in Chemical, Biomedical, Mechanical, or related Engineering or Scientific Degree
Experience
Ideal candidate will have 6 - 9 years experience working in a manufacturing environment or related technical fast paced, impactful environment.
Knowledge, Skills, Abilities
Ability to work independently, coordinate and lead projects based upon established timelines and budget.
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.
This position requires occasional travel to other Thermo Fisher Scientific, customer, and partner sites worldwide (approx 0 – 10%).
Compensation and BenefitsThe salary range estimated for this position based in New York is $83,300.00–$115,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
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
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewardsThermo 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.