Manufacturing Equipment Operator- Sterile B Shift- BFS - copy

Unifin SAS • Town of Henrietta, NY

68d • $19 - $21 • Onsite

About The Position

As a French pharmaceutical industrial group, Unither strives 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, Unither has 10 sites on 4 continents and more than 2400 employees. Since 2013, the Unither Manufacturing LLC. site in Rochester (NY) specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules, and has more than 360 employees. The Manufacturing Equipment Operator is responsible for manufacturing pharmaceutical batches by setting up, cleaning, operating, and maintaining equipment. This role executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines, and any other related regulations. The operator is expected to fully participate in departmental projects and quality working teams. This position is responsible for the hands-on execution of activities related to the manufacturing or packaging of products, supporting leaders and subject matter experts, and supporting production, operations projects, and process improvements. The role requires maintaining accurate and complete documentation, monitoring and maintaining product and process quality, and working with other Associates to minimize downtime during startup. The operator will perform and verify the integrity of sterilizing grade filters used in product transfers, work in a classified area (ISO 7) while dressed in clean room gown for extended periods, and must obtain and maintain clean room gowning certification. Good clean room techniques must be followed when manufacturing batches. The role involves using and troubleshooting Supervisory Control Systems for batch processing and cleaning/steaming of tanks and transfer lines, sampling pH readings, and performing titrations. Attention to detail is critical to ensure batch sterility. The operator performs integrity testing of sterilizing grade air and product filters using bubble point and diffusion testing methods.

Requirements

• HS Diploma/GED with minimum of 2 years of experience in pharmaceutical production experience and a demonstrated level of sound technical skill.
• Must have prior experience working in a high-speed manufacturing environment.
• Must have demonstrated competence with the operation and function of multiple pieces of equipment.
• Demonstrate 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). This would include basic algebra and geometry.
• 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.
• Mental/visual attention plus manual coordination.
• 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.
• 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.).

Nice To Haves

• AAS or BS desirable.
• 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.
• Demonstrates qualities that would enable him/her to train other employees.

Responsibilities

• Prepares for production by reviewing the production schedule, understanding deliverables, and reviewing applicable SOP’s, 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 production schedule.
• Receives and distributes supplies into production area, as necessary.
• Executes equipment qualification protocols and validation protocols.
• Operates general production equipment ensuring its proper operation and adhering 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. Elevates issues when work orders are placed.
• 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, waste reductions, etc.
• Prepares equipment for next run by performing cleaning. This 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 as well as his/her supervisor.
• Ensures all paperwork is completed thoroughly and accurately prior to the end of the shift.
• Follows all HSSE rules and regulations. Accepts accountability for own personal safety and identifies potential unsafe conditions to help prevent self and co-workers from being injured.
• Complies with all site security requirements.
• Ensures that actions do not create a negative impact on the environment.

Benefits

• 100% employer-paid medical premiums
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses and merit increase eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED