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About the Role

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. The operator is expected to fully participate in departmental projects and quality working teams, supporting the hands-on execution of activities related to product manufacturing or packaging.

Responsibilities

Prepares for production by reviewing the production schedule, understanding deliverables, and reviewing applicable SOP’s and 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.
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.
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, 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 as well as 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.
Performs, and verifies, integrity of sterilizing grade filters used in product transfers.
Works in a classified area (ISO 7) while dressed in clean room gown for extended periods of time.
Obtains and maintains clean room gowning certification.
Abides by good clean room techniques when manufacturing batch.
Uses, and troubleshoots, Supervisory Control Systems during manufacture of batches.
Samples pH readings and performs titrations.
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.
Prior experience working in a high-speed manufacturing environment.
Demonstrated competence with the operation and function of multiple pieces of equipment.
Knowledge of computer applications and current software.
Basic mechanical and manufacturing processes knowledge and aptitude preferred.
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.
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.).

Skills

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).
Basic algebra and geometry.
Demonstrates qualities that would enable him/her to train other employees.
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.

Location

Rochester, NY

Work Type

Full-time
Onsite

Experience Level

Minimum of 2 years of experience in pharmaceutical production
Minimum of 2 years of experience in high-speed manufacturing

Education Level

HS Diploma/GED
AAS or BS desirable

Salary/Compensations

19.00 - 21.09 USD per hour

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

About the Company

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.
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation.
We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

Equal Opportunity

Unither is an Equal Opportunity Employer.
We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.