Manufacturing Equipment Operator- Sterile B Shift- BFS - copy
Unither Pharma
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Benefits offered by this job
Job summary
Unither Pharma is seeking a Manufacturing Equipment Operator- Sterile for the BFS line in Rochester, NY. You will set up, operate, clean and maintain equipment, following cGMP, SOPs and safety guidelines to ensure sterile batch integrity.
Reporting to the Manufacturing Supervisor, you will participate in projects, document activities, and support process improvements while adhering to clean room and gowning requirements for ISO 7 environments.
Qualifications
- Requires HS Diploma or GED with 2+ years of pharma production experience.
- AAS or BS are desirable qualifications.
- Demonstrated basic math skills and ability to train others.
Responsibilities
- Prepare for production by reviewing schedule and SOPs; ensure materials and documents are available.
- Operate and monitor general production equipment following procedures; record critical parameters.
- Complete forms and logs; troubleshoot and communicate equipment or quality issues.
- Perform cleaning and routine maintenance; ensure equipment is ready for next run.
- Follow HSSE rules and maintain clean room gowning and GMP standards.
Skills
Education
Job description
Manufacturing Equipment Operator- Sterile B Shift- BFS - copy
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.
Monday- Friday 3pm-11:30pm
*Please note this will be changing to a 12-hour (ABCD) shift schedule
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.
- 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.
- 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.
- 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.
- 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.
- Works mainly in a manufacturing environment with some disagreeable elements such as noise, dust, fumes, heat, safety hazards, etc.
- 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.).
19.00 - 21.09USD
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.
At Unither, your base salary is just the beginning. Our Total Rewards include:
- 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 contributionswith wellness incentives
- Annual performance bonuses and merit increase eligibility
- And more—because we invest in your health, your future, and your peace of mind.
It’s a package designed to reward impact—not just hours worked.
At Unither, we don’t
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