We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 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 300 employees.
JOB SUMMARY:
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. The Manufacturing Equipment Operator is expected to fully participate in both departmental projects and any quality working teams that may be applicable. This position shall be responsible for the hands-on execution of activities as they relate to the manufacturing or packaging of products. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and complete documentation on all activities. Responsible for monitoring and maintaining quality of product and processes. Will require working with other Associates to minimize downtime during startup process. Perform, and verify, integrity of sterilizing grade filters used in product transfers. 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 batch, manufacturing associates are to abide by good clean room techniques. Will use, and troubleshoot, Supervisory Control Systems during manufacture of batches; these are heavily automated systems used for batch processing and cleaning and steaming of tanks and transfer lines. Ability to sample pH readings and perform titrations. Attention to detail is critical as an oversight can compromise the sterility of a batch. Performs integrity testing of sterilizing grade air and product filters using bubble point and diffusion testing methods.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Room & Process Ready for Production Run (25%)
- 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.
Product Ready for Further Processing (25%)
- 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.
Equipment & Room Ready for Next Production Run (25%)
- 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.
Safe Work Environment (25%)
- 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.
EDUCATION & EXPERIENCE:
- HS Diploma/GED with minimum of 2 years of experience in pharmaceutical production experience and a demonstrated level of sound technical skill.
- AAS or BS desirable.
QUALIFICATIONS/EXPERIENCE:
- 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.
- 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.
KNOWLEDGE SKILLS & ABILITIES:
- 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.
- Demonstrates qualities that would enable him/her to train other employees.
SCOPE OF DECISION-MAKING: Decisions require some judgment. Perform repetitive or routine duties working from detailed instructions and under standard procedures. Requires making minor decisions.
LEVEL OF SUPERVISION PROVIDED: Individual contributor.
INTERNAL / EXTERNAL CONTACTS: Regular inside and outside: Requires contacts to carry out company policy and programs. Improper handling will have considerable effect on operating results. Must often deal with people of substantially higher rank on matters requiring explanation, persuasion and obtaining approvals.
PHYSICAL REQUIREMENTS/ENVIRONMENT:
Works mainly in a manufacturing environment with some disagreeable elements such as noise, dust, fumes, heat, safety hazards, etc.
Details of physical requirements:
- 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.
- 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 flexible schedule and/or overtime. Days and hours of work are subject to change due to production schedules.
