**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office **Job Description** **Day Shift 7:30-3:00 Monday- Friday** **Responsibilities** + Applies Good Manufacturing Practices (GMP) in all areas of responsibility + Demonstrates and promotes the company vision of the 4 l's: Integrity, Intensity, Innovation, Involvement + Conducts all activities in a safe and efficient manner + Performs engineering/qualification protocol activities for label manufacturing equipment (line trials, URS, FMEA, FAT/SAT, IQ, OQ, PQ) according to company procedures, GMP, and Good Engineering Practices to ensure equipment is fit for production + Completes material qualification protocols for clinical label products using various test equipment. + Assists with the coordination and execution of Factory and Site Acceptance Testing (FAT/SAT) + Provides regular engineering presence on the manufacturing floor + Coordinates vendor technicians during equipment upgrades & testing, ensuring alignment to GEP, GMP, and company policies + Assists Validation and Process Engineers in the identification/development/qualification of new equipment, tooling, materials, processes, and technologies into manufacturing + Assists Validation & Process Engineers with the development of test plans to ensure risk mitigation and quality requirements are met + Authors qualification reports summarizing results of protocol execution + Assists in performing equipment & process gap analyses, leading to the identification of equipment/tooling requirements + Maintains list of calibrated equipment and ensures calibrations are performed by third party services as per calibration schedule + Finds opportunities for and assists with implementing process optimization and quality improvement in manufacturing in line with the Thermo Fisher Scientific Practical Process Improvement (PPI) program + Identifies equipment safety improvements and collaborates with the Environmental, Health, and Safety specialist to implement + Support internal quality team and company & customer packaging sites in investigating issues related to label application, as needed + Other duties may be assigned to meet business needs **Knowledge, Skills, Abilities** + B.S. in Engineering field or applied science from a four-year accredited college or university + Mechanically inclined, no issues interacting with production equipment and operating test equipment in a lab environment + Continuous improvement approach + Ability to collaborate with teams comprised of various functions + Organization + Multitasking + Effective at delivering technical concepts to non-technical audiences + Analytical problem solving skills (PDCA) + Proficiency in personal computer applications (e.g. Microsoft Outlook, Word, Excel) + Ability to lift up to 50 lb. as needed **Preferred Experience and Skills** + Minimum of 2 years equipment/process validation, calibration, or quality engineering experience in a regulated environment (cGMP/ISO/Defense) + Experience with Quality Management Systems preferred (e.g. TrackWise) + Experience with Computerized Maintenance Management Systems (CMMS) (e.g. IBM Maximo) **Compensation and Benefits** The hourly pay range estimated for this position based in New York is $28.16–$42.25. 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-rewards Thermo 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.