Manufacturing Equipment Operator - C Shift- BFS

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

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 that could apply. This position is expected to fully participate in both departmental projects and any quality working teams that may be applicable.

This role involves hands-on execution of activities related to the manufacturing or packaging of products, supporting the leader and subject matter expert in their area(s) of responsibility, and contributing to production, operations projects, and process improvements. The operator maintains accurate and complete documentation on all activities and is responsible for monitoring and maintaining the quality of product and processes.

Requires working in a classified area (ISO 7) while dressed in clean room gown for extended periods of time. Must be able to obtain and maintain clean room gowning certification. When manufacturing a batch, associates must abide by good clean room techniques. The role involves using and troubleshooting Supervisory Control Systems during batch processing and cleaning, as well as performing integrity testing of sterilizing grade filters using bubble point and diffusion testing methods.

Responsibilities

• Room & Process Ready for Production Run (25%)
  • Prepares for production by reviewing the production schedule, understanding deliverables, and reviewing applicable SOPs and any procedure changes.
  • Ensures that supplies, materials, and documents are available as required 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 protocols and validation protocols.
• Product Ready for Further Processing (25%)
  • Operates general production equipment, ensuring its 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.
  • Keeps equipment operating by following operating instructions, troubleshooting breakdowns, and placing work orders for repairs.
  • Provides input regarding opportunities for improvement, waste reduction, etc., to supervision and/or during team meetings.
  • 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, which may include manually cleaning portable equipment and small parts.
  • Performs routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion.
  • Ensures equipment conditions are acceptable to pass to incoming shifts.
  • Communicates any ongoing equipment, material, or quality concerns to incoming teams and supervisors.
  • Ensures all paperwork is completed thoroughly and accurately prior to the end of the shift.
• Safe Work Environment (25%)
  • Follows all HSSE rules and regulations.
  • Accepts accountability for personal safety and identifies potential unsafe conditions to help prevent injuries.
  • Complies with all site security requirements.
  • Ensures actions do not create a negative impact on the environment.

Requirements

• HS Diploma/GED with a minimum of 2 years of experience in pharmaceutical production and a demonstrated level of sound technical skill.
• AAS or BS 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.
• 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

• Demonstrates basic math skills in multiplication, division, percentage calculation, significant figures, conversion from metric to standard measures (or inverse), and weight to volume measures (or inverse), including basic algebra and geometry.
• Demonstrates qualities that enable training of other employees.

Physical Requirements

• Works mainly in a manufacturing environment with some disagreeable elements such as noise, dust, fumes, heat, and safety hazards.
• Must be able to lift 50 pounds to lift and maneuver bulk containers of ingredients.
• Must have physical mobility and dexterity to frequently stand, bend, push, twist, kneel, climb, stoop, and reach overhead, and able to stand for extended periods of time while performing duties.
• Considerable mental/visual concentration, coordinating manual dexterity with mental/visual attention.
• Must be able to successfully pass the Ishihara & Jaeger vision test and/or must be qualified to perform the essential functions of the job with or without reasonable accommodation.
• Must be able to operate power equipment; routinely drives/operates lifts.
• Must be able to work safely with materials and equipment; works with 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.).
• Must be available for a flexible schedule and/or overtime. Days and hours of work are subject to change due to production schedules.

Pay

Compensation Range: $19.00 - $21.09 USD per hour. The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, 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.
• No paycheck deductions for healthcare, which can be worth an extra $1 to $3.50 an hour compared to jobs where you pay part of the premium.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage, and Innovation. We are committed to providing working conditions and an atmosphere conducive to development and the expression of potential, with a high degree of autonomy and initiative encouraged.