Manufacturing Engineering Technician

Thermo Fisher Scientific; Bohemia (NY); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in pharmaceuticals is seeking a Manufacturing Engineering Technician to support the label manufacturing process. This role involves applying Good Manufacturing Practices (GMP), conducting engineering and qualification activities, and ensuring safety on the production floor. The ideal candidate has a bachelor’s degree in engineering and is experienced in validation processes. Competitive pay and comprehensive benefits are offered, promoting a safe and collaborative work environment.

Benefits

Health insurance

Employee assistance programs

PTO and paid holidays

401(k) retirement plan

Qualifications

• Minimum of 2 years equipment/process validation experience in a regulated environment preferred.
• Mechanically inclined and effective at delivering technical concepts to non-technical audiences.

Responsibilities

• Conducts engineering/qualification activities for manufacturing equipment per GMP and company procedures.
• Author qualification reports and identify equipment safety improvements.
• Coordinates with vendor technicians during equipment upgrades.

Skills

Problem Solving

Collaboration

Multitasking

Analytical Thinking

Education

B.S. in Engineering field or applied science

Tools

Quality Management Systems

Computerized Maintenance Management Systems

Job description

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Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office

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

Day Shift 7:30-4:00 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

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Production, Supply Chain, and Manufacturing

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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