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- FridayResponsibilitiesApplies Good Manufacturing Practices (GMP) in all areas of responsibilityDemonstrates and promotes the company vision of the 4 l's: Integrity, Intensity, Innovation, InvolvementConducts all activities in a safe and efficient mannerPerforms 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 productionCompletes 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 floorCoordinates vendor technicians during equipment upgrades & testing, ensuring alignment to GEP, GMP, and company policiesAssists Validation and Process Engineers in the identification/development/qualification of new equipment, tooling, materials, processes, and technologies into manufacturingAssists Validation & Process Engineers with the development of test plans to ensure risk mitigation and quality requirements are metAuthors qualification reports summarizing results of protocol executionAssists in performing equipment & process gap analyses, leading to the identification of equipment/tooling requirementsMaintains list of calibrated equipment and ensures calibrations are performed by third party services as per calibration scheduleFinds opportunities for and assists with implementing process optimization and quality improvement in manufacturing in line with the Thermo Fisher Scientific Practical Process Improvement (PPI) programIdentifies equipment safety improvements and collaborates with the Environmental, Health, and Safety specialist to implementSupport internal quality team and company & customer packaging sites in investigating issues related to label application, as neededOther duties may be assigned to meet business needs

Knowledge, Skills, AbilitiesB.S. in Engineering field or applied science from a four-year accredited college or universityMechanically inclined, no issues interacting with production equipment and operating test equipment in a lab environmentContinuous improvement approachAbility to collaborate with teams comprised of various functionsOrganizationMultitaskingEffective at delivering technical concepts to non-technical audiencesAnalytical 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 SkillsMinimum 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