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About the Role

As an Equipment Operator, you will play a critical role in supporting the safe, accurate and efficient production of clinical trial labels. You will operate computerized and automated equipment used to print, inspect, process and manufacture a variety of label constructions according to client-approved specifications.

Responsibilities

• Set up, operate and monitor automated and non-automated label manufacturing, printing and inspection equipment in accordance with approved production documentation.
• Manufacture a wide variety of clinical label constructions according to client-approved proofs, specifications and associated documentation.
• Set up computerized production runs and process variable and/or static label information using proprietary software applications, including CLPS.
• Monitor label production throughout the manufacturing process to ensure accuracy, completeness and conformance to established quality standards.
• Apply cGMP requirements, SOPs and WIs in all areas of responsibility while maintaining accurate and complete production documentation.
• Perform equipment setup, changeovers, adjustments and basic troubleshooting to support efficient production and minimize downtime.
• Handle rolled and/or fanfold label materials and perform activities such as roll splicing and bulk label transfers, as applicable to assigned equipment.
• Inspect finished product and maintain accountability for product quality throughout the manufacturing process.
• Independently plan and execute assigned production activities while effectively communicating issues, priorities and status with team members and internal customers.
• Perform routine equipment cleaning and support preventive maintenance activities in accordance with established procedures and safety guidelines.
• Maintain a clean, organized and safe work environment.
• Cross-train on multiple pieces of equipment and processes to support changing production and business needs.

Requirements

• High school diploma or equivalent required.
• Minimum of 2 years of work experience in manufacturing, operations, production, laboratory operations or a related environment.
• Experience working in a cGMP-regulated environment.
• Experience in printing, labeling, packaging or a related manufacturing environment.
• Experience operating computerized, automated or digital inkjet equipment.
• Strong computer literacy, including experience with data transfer, file management and computerized equipment interfaces.
• Working knowledge of Microsoft Excel and Outlook.
• Mechanical aptitude with the ability to operate, adjust and troubleshoot production equipment.
• Ability to accurately read and interpret measurements, specifications, production documentation and work instructions.
• Strong attention to detail with a commitment to quality and accountability for finished product.
• Analytical and problem-solving skills with the ability to identify equipment or material issues and determine appropriate solutions.
• Ability to work with various label constructions and materials, including rolled and fanfold materials.
• Ability to perform manual material handling and roll splicing activities, as required.
• Strong organizational and time-management skills with the ability to effectively manage multiple priorities in a fast-paced environment.
• Ability to follow detailed cGMP documentation requirements and established procedures.
• Ability to handle confidential information and communicate professionally with colleagues and internal customers.
• Ability and willingness to cross-train and operate multiple pieces of production equipment.
• Ability to work both independently and collaboratively as part of a team.
• Ability to wear required Personal Protective Equipment (PPE) and follow applicable safety and chemical hygiene requirements.
• Ability to stand and move throughout the workday, including reaching, bending, stooping and grasping.
• Ability to use hand tools and production equipment requiring gripping, grasping, pushing and pulling.
• Ability to lift and maneuver materials weighing up to 50 pounds unassisted.
• Able to lift 40 lbs. without assistance.
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards.
• Loud Noises (Equipment/Machinery).
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.).
• Standing for full shift.
• Strong Odors (chemical, lubricants, biological products etc.).
• Warehouse.
• Will work with hazardous/toxic materials.

Skills

• cGMP
• SOPs
• Work Instructions
• CLPS
• Microsoft Excel
• Microsoft Outlook
• Mechanical aptitude
• Attention to detail
• Analytical skills
• Problem-solving skills
• Organizational skills
• Time-management skills
• Communication skills

Location

• Bohemia, New York

Work Type

• Third Shift (Nights)
• 2nd Shift: 3:00 p.m. – 11:30 p.m.
• 3rd Shift: 11:00 p.m. – 7:30 a.m.

Experience Level

• Minimum of 2 years of work experience in manufacturing, operations, production, laboratory operations or a related environment.

Education Level

• High school diploma or equivalent

Salary/Compensations

• $24.00 – $26.00 per hour
• $19.64–$29.45

Benefits

• Additional shift differential applies to 2nd and 3rd shift positions.
• Competitive hourly pay rate of $24.00 – $26.00 per hour
• Annual performance-based bonus
• Annual merit-based increase
• Medical, dental and vision benefits effective Day 1
• Paid Time Off and designated paid holidays
• Retirement Savings Plan
• Tuition reimbursement
• Employee Referral Bonus
• Career advancement opportunities
• 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

About the Company

• 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.
• We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, including protecting the environment, ensuring food safety and helping find cures for cancer.
• Clinical Labeling Services, part of the Clinical Trials Division and located in Bohemia, New York, provides leading clinical label design, production and management services for the pharmaceutical and biotechnology industries.
• Our advanced inspection software, in-house variable and non-variable print capabilities, and proprietary translation and regulatory approval systems are designed to reduce overall clinical trial label cycle times.