Manufacturing Equipment Operator- Sterile B Shift- BFS - copy

Unither Pharmaceuticals•Rochester, NY

1d•Onsite

About The Position

Unither Manufacturing LLC., based in Rochester, New York, manufactures Blow-Fill-Seal, Liquid Stick-Packs, pharmaceutical bottles, tablets, and capsules. The Manufacturing Equipment Operator manufactures pharmaceutical batches by setting up, cleaning, operating, and maintaining equipment. The role executes production processes in accordance with cGMP, standard operating procedures, documentation protocols, environmental health and safety guidelines, and applicable regulations. The operator participates in departmental projects and quality working teams, performs hands-on manufacturing or packaging activities, supports the area leader and subject matter experts, and contributes to production projects and process improvements. The position monitors and maintains product and process quality, maintains accurate records, and works with other associates to minimize downtime during startup. Duties include verifying the integrity of sterilizing-grade filters used in product transfers, sampling pH and performing titrations, and using and troubleshooting automated supervisory control systems for batch processing and cleaning and steaming tanks and transfer lines. The role requires working in an ISO 7 classified area while wearing cleanroom garments for extended periods and obtaining and maintaining cleanroom gowning certification. Attention to detail is essential to protect batch sterility. The position reports to the Manufacturing Supervisor. The posted schedule is Monday through Friday, 3:00 p.m. to 11:30 p.m.; the schedule is expected to change to a 12-hour ABCD shift schedule. Compensation is listed as $19.00–$21.09 per hour. Unither describes its total rewards as including employer-paid medical premiums, 401(k) contributions, HSA contributions with wellness incentives, annual performance bonuses, and eligibility for merit increases.

Requirements

High school diploma or GED and at least 2 years of pharmaceutical production experience, with demonstrated sound technical skill.
Prior experience in a high-speed manufacturing environment.
Demonstrated competence operating and understanding multiple pieces of equipment.
Basic math skills, including multiplication, division, percentages, significant figures, metric-to-standard and standard-to-metric conversions, weight-to-volume measures, basic algebra, and geometry.
Ability to demonstrate qualities suitable for training other employees.
Ability to obtain and maintain cleanroom gowning certification and work in a classified area while gowned.
Ability to lift and maneuver containers weighing up to 50 pounds.
Physical mobility and dexterity to frequently stand, bend, push, twist, kneel, climb, stoop, reach overhead, and stand for extended periods.
Ability to pass the Ishihara and Jaeger vision tests, or perform the essential functions with or without reasonable accommodation.
Ability to operate power equipment and routinely drive or operate lifts.
Ability to work safely with materials and equipment, including chemicals, tools, and machinery.
Ability to wear required safety glasses, safety shoes, gloves, other protective items, and cGMP garments and coverings.
Ability to work in a manufacturing environment with noise, dust, fumes, heat, safety hazards, and variable but moderately high noise levels.
Ability to coordinate manual dexterity with mental and visual attention.

Nice To Haves

Associate of Applied Science or bachelor's degree.
Aseptic and cleanroom experience.
Experience working under aseptic conditions while fully gowned.
Experience in compounding and/or batch processing.
Demonstrated leadership capabilities.
General understanding of material-handling machinery.
Knowledge of computer applications and current software.
Basic mechanical and manufacturing-process knowledge and aptitude.

Responsibilities

Prepare for production runs by reviewing schedules, deliverables, applicable SOPs, and procedure changes.
Ensure required supplies, materials, and documents are available; receive and distribute supplies as needed and coordinate with other departments to support the production schedule.
Execute equipment qualification and validation protocols.
Operate production equipment, monitor and record critical process parameters, and document production activities, equipment, and batches accurately.
Troubleshoot equipment breakdowns, submit repair work orders, and escalate issues.
Provide input on improvement and waste-reduction opportunities and support process-improvement, cycle-time-reduction, and waste-reduction efforts.
Clean and prepare equipment for the next production run, including manual cleaning of portable equipment and small parts; perform routine maintenance and GMP-compliant cleaning.
Ensure equipment is ready for incoming shifts and communicate equipment, material, or quality concerns to incoming teams and the supervisor.
Complete all paperwork thoroughly and accurately before the end of the shift.
Follow HSSE rules, site security requirements, and practices that prevent injury and avoid negative environmental impacts.
Perform and verify integrity testing of sterilizing-grade filters used in product transfers, including sterilizing-grade air and product filters using bubble point and diffusion testing methods.
Use and troubleshoot supervisory control systems during batch manufacturing, processing, and equipment cleaning and steaming.
Sample pH readings and perform titrations.
Work with associates to minimize startup downtime and support production operations.