Manufacturing Equipment Operator- C Shift

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible. As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees. Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees.

About the role

Reporting to the Manufacturing Supervisor, the Manufacturing Equipment Operator is responsible for manufacturing pharmaceutical batches by setting up, cleaning, operating, and maintaining equipment. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines, and any other related regulations. This position supports departmental projects and quality working teams, and is responsible for the hands-on execution of activities related to the manufacturing or packaging of products. The role involves working in a classified area (ISO 7) while dressed in clean room gown for extended periods, and requires maintaining accurate documentation, monitoring product and process quality, and troubleshooting automated systems.

Schedule

Monday–Friday, 11:00 PM–7:30 AM

Responsibilities

• Room & Process Ready for Production Run (25%)
  • Prepares for production by reviewing the production schedule, understanding deliverables, and reviewing applicable SOPs and procedure changes.
  • Ensures supplies, materials, and documents are available to meet the production schedule.
  • Works with other departments to ensure adherence to the production schedule.
  • Receives and distributes supplies into the production area as necessary.
  • Executes equipment qualification and validation protocols.
• Product Ready for Further Processing (25%)
  • Operates general production equipment, ensuring proper operation and adherence to production procedures.
  • Monitors and records critical process parameters.
  • Documents production by completing forms, reports, logs, and records of equipment and batches.
  • Troubleshoots equipment breakdowns, places work orders for repairs, and escalates issues.
  • Provides input on opportunities for improvement, waste reduction, and process enhancements.
  • Supports implementation of process improvement efforts, cycle time reductions, and waste reductions.
• Equipment & Room Ready for Next Production Run (25%)
  • Prepares equipment for the next run by performing cleaning, including manually cleaning portable equipment and small parts.
  • Performs routine maintenance and cleaning of production equipment to maintain GMP standards.
  • Ensures equipment conditions are acceptable for incoming shifts and communicates ongoing concerns.
  • Completes all paperwork thoroughly and accurately prior to the end of the shift.
• Safe Work Environment (25%)
  • Follows all HSSE (Health, Safety, Security, and Environment) rules and regulations.
  • Accepts accountability for personal safety and identifies potential unsafe conditions to prevent injuries.
  • Complies with all site security requirements.
  • Ensures actions do not create a negative impact on the environment.
• Performs integrity testing of sterilizing-grade filters using bubble point and diffusion testing methods.
• Samples pH readings and performs titrations with strict attention to detail to avoid compromising sterility.
• Uses and troubleshoots Supervisory Control Systems for batch processing, cleaning, and steaming of tanks and transfer lines.
• Works collaboratively with other associates to minimize downtime during startup processes.
• Maintains clean room gowning certification and adheres to good clean room techniques during manufacturing.

Requirements

• High School Diploma or GED with a minimum of 2 years of experience in pharmaceutical production and demonstrated technical skill.
• AAS or BS degree is desirable.
• Prior experience working in a high-speed manufacturing environment.
• Demonstrated competence with the operation and function of multiple pieces of equipment.
• Aseptic and clean room experience is preferred.
• Experience working under aseptic conditions while fully gowned is desirable.
• Prior experience in compounding and/or batch processing is preferred.
• Demonstrated leadership capabilities are preferred.
• General understanding of material handling machinery is advantageous.
• Knowledge of computer applications and current software.
• Basic mechanical and manufacturing processes knowledge and aptitude preferred.

Skills

• Basic math skills, including multiplication, division, percentage calculation, significant figures, metric-to-standard conversions, and weight-to-volume measures (including basic algebra and geometry).
• Ability to train other employees.

Physical Requirements

• Works mainly in a manufacturing environment with elements such as noise, dust, fumes, heat, and safety hazards.
• Must be able to lift 50 pounds to maneuver bulk containers of ingredients.
• Physical mobility and dexterity to frequently stand, bend, push, twist, kneel, climb, stoop, and reach overhead; able to stand for extended periods.
• Considerable mental and visual concentration, coordinating manual dexterity with attention.
• Must successfully pass the Ishihara & Jaeger vision test or qualify to perform essential functions with reasonable accommodation.
• Must be able to operate power equipment and routinely drive/operate lifts.
• Must work safely with materials, chemicals, tools, and equipment.
• May work in an environment with variable but moderately high noise levels (hearing protection recommended).
• Must wear safety glasses, safety shoes, gloves, and other protective items as required.
• Must wear appropriate garments and coverings per cGMP (uniforms, hair/beard nets, etc.).

Pay

Compensation range: $19.00 – $21.09 USD per hour. Individual annual salaries/hourly rates will be determined based on factors including market data, education, experience, qualifications, expertise, and internal equity considerations.

Benefits

• 100% employer-paid medical premiums (a $2,000–$6,000+ annual value).
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution.
• HSA contributions with wellness incentives.
• Annual performance bonuses and merit increase eligibility.
• Total rewards package designed to invest in health, future, and peace of mind.

At Unither, we pay 100% of your medical premiums, meaning no paycheck deductions for healthcare—equivalent to an extra $1 to $3.50 per hour compared to jobs where you pay part of the premium.