Sr Operator - Third Shift

Thermo Fisher Scientific•Fairport, NY

About The Position

The Senior Operator supports daily manufacturing and production activities in a regulated environment, working with Production Leadership, Quality, Maintenance, and other support functions to ensure products are manufactured safely, efficiently, and in accordance with established procedures and quality requirements. The role serves as an experienced resource for other operators and supports production execution, employee training, troubleshooting, documentation accuracy, and continuous improvement. The position involves manufacturing, filling, packaging, labeling, inspection, and related production activities; operating and maintaining production equipment; reviewing controlled production documentation; and coordinating materials and work across the production process. The Senior Operator also helps with daily assignments and line coordination, communicates production status and concerns, and promotes safe, compliant, and efficient operations. This is a third-shift (night) role in a manufacturing environment. Work may take place in controlled manufacturing, cleanroom, refrigerated, or other specialized areas. The role requires extended periods standing and walking, lifting or moving materials within site limits, and wearing required personal protective equipment. Cleanroom restrictions may apply, including limits on hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair.

Requirements

High school diploma, secondary education, advanced certificate, or equivalent required.
At least 2 years of experience in manufacturing, production, operations, packaging, laboratory operations, or a related field.
Strong understanding of manufacturing processes, production procedures, and GMP/cGMP.
Ability to read, understand, and consistently follow SOPs, Work Instructions, production records, and other controlled documentation.
Strong attention to detail and ability to complete manufacturing documentation accurately and thoroughly.
Ability to recognize process, equipment, documentation, safety, and quality issues and escalate concerns appropriately.
Mechanical aptitude and ability to perform basic equipment troubleshooting and approved adjustments.
Strong organizational and time-management skills, including the ability to prioritize multiple production activities.
Ability to work independently and collaboratively with a production team.
Strong verbal and written communication skills.
Ability to train, coach, and guide less-experienced operators.
Ability to communicate effectively with Production Leadership, Quality, Maintenance, Engineering, Warehouse, and other support functions.
Commitment to safety, quality, compliance, and continuous improvement.
Ability to use manufacturing systems, computers, electronic documentation systems, and standard business applications as required.
Ability to work effectively in a fast-paced manufacturing environment while maintaining accuracy and compliance.
Ability to identify process improvement opportunities and participate in Lean, 5S, and continuous improvement activities.
Dependable attendance and ability to support production schedules, including overtime, weekends, or alternate shifts when required.
Ability to stand and walk for extended periods and to bend, reach, stoop, push, pull, and perform repetitive manufacturing activities.
Ability to lift and/or move materials and equipment within established site lifting requirements.
Ability to safely operate production equipment and material-handling devices for which properly trained and authorized.
Ability to wear required PPE, which may include safety glasses, gloves, safety footwear, hearing protection, protective clothing, and cleanroom garments.
Must follow Environmental Health and Safety, Quality, GMP, and site-specific requirements.

Nice To Haves

Technical, vocational, manufacturing, or related certification, where applicable.
Experience in a cGMP/GMP-regulated manufacturing environment.
Previous experience serving as a senior operator, trainer, lead operator, or subject matter expert.
Experience operating, setting up, cleaning, and troubleshooting manufacturing or packaging equipment.
Experience completing and reviewing controlled manufacturing documentation.
Experience working in a cleanroom or controlled manufacturing environment, where applicable.

Responsibilities

Perform and coordinate manufacturing, filling, packaging, labeling, inspection, and other production activities according to approved procedures, production records, and schedules.
Set up, operate, monitor, clean, and make routine adjustments to manufacturing and production equipment.
Guide, coach, and provide hands-on training to Operators I and II on processes, equipment, documentation, safety, and quality requirements.
Assist Production Leadership with daily work assignments, line coordination, staffing needs, workflow, and production priorities.
Verify that production activities follow approved SOPs, Work Instructions, Batch Records, Production Manufacturing Records, and applicable cGMP requirements.
Perform and document in-process checks, inspections, measurements, and verifications accurately and at the required frequency.
Review production documentation for accuracy, completeness, legibility, and compliance; identify discrepancies and ensure they are addressed according to procedures.
Monitor equipment and processes for abnormalities, quality concerns, and potential equipment issues; perform first-level troubleshooting and approved adjustments, and escalate complex issues appropriately.
Communicate quality, safety, equipment, material, or process concerns promptly and support investigations when required.
Ensure proper material identification, handling, reconciliation, staging, and movement; maintain accurate inventory and production records and segregate and identify materials and products appropriately.
Perform line and equipment clearance, cleaning, sanitation, and changeover activities according to established procedures.
Support startup, shutdown, and product changeover activities to minimize downtime and maintain production schedules.
Follow required safety procedures and PPE requirements; maintain a clean, safe, organized, and inspection-ready work environment through 5S and good housekeeping.
Participate in continuous improvement initiatives focused on safety, quality, productivity, waste reduction, equipment performance, and operational efficiency; assist with corrective and preventive actions and process improvements.
Promote teamwork, accountability, quality, safety, and adherence to procedures on the production floor.
Communicate production status, equipment issues, quality concerns, and outstanding actions during shift handoffs and daily production meetings.
Perform other duties as assigned to support business and operational needs.

Benefits

Competitive pay.
Performance-related bonus where eligible and variable annual bonus eligibility under company policy.
Annual merit performance-based increase.
Medical, dental, and vision plans, including health incentive programs.
Paid time off or annual leave, including at least 120 hours of PTO and 10 paid holidays annually.
Employee referral bonus.
Career advancement opportunities.
Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
Paid parental leave, including 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.
401(k) retirement savings plan.
Employee Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.