Production Operator

LanceSoft Inc; Lombard (IL); On-site; USD 35,000 - 55,000; Full time

Job summary

A leading company is hiring an Operator 1 to manage equipment for filling and packaging Prepared Culture Media. This role involves ensuring compliance with cGMP standards, performing quality checks, and troubleshooting production machines. The ideal candidate will have at least two years of manufacturing experience and a strong knowledge of safety regulations.

Qualifications

• 2 years in a regulated production/operations environment.
• Experience with high-speed automated production equipment.
• Familiarity with OSHA and FDA regulations.

Responsibilities

• Operate and troubleshoot production machines for filling and packaging media.
• Complete batch documentation and maintain compliance with SOPs.
• Perform AQL inspections and ensure product quality.

Skills

Attention to detail

Problem solving

Technical interpretation

Education

High School Diploma or GED

Job description

We are hiring for our 2pm - 10:30pm shift (Monday - Friday) The schedule is 8 x 5-hour days, with overtime anticipated.
Candidates must be available for overtime.

Position Summary:
The Operator 1 position is responsible for the operation of equipment used in the filling and plating of Prepared Culture Media plates, bottle and tubes in a cGMP compliant manner.
2 years minimum experience in manufacturing and machine operating experience. Not warehouse packaging
• The individual will perform or assist in the setup, inspection, operation, preventive maintenance, troubleshooting and cleaning of equipment used throughout the Prepared Culture Media filling/bottling processes.
• Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks. • The individual will also perform all ancillary tasks to support routine production, including area cleaning and 5S, movement of materials, AQL inspections, reworks, material reconciliation, and other tasks deemed necessary by production management.

Primary Duties:
1. Production
- Set-up, operate and troubleshoot as needed on various production machines for filling and high-speed packaging of Prepared Culture Media using HMI/SCADA interfaces.
- Operate a manufacturing process within controlled cleanrooms while meeting guidelines for production process flow. - Perform equipment and component preparation tasks in non-controlled areas to meet batch processing timelines.
- Perform necessary calibrations and verifications of filling and packaging equipment.
- Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs
- Perform ancillary cleaning and sanitization activities of production equipment and areas.
2. Quality
- Ensure that all batch documentation is completed in an accurate, thorough, and timely manner and in accordance with Good Documentation Practices.
- Perform in-process and AQL inspections to meet batch quality requirements.
- Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
- Assist with manufacturing deviation analysis, CAPA actions, and other process equipment related quality concerns
- Maintain all work areas in a well-organized, clean and tidy manner at all times in accordance with the outlined 5S standards.
- Understand and follow aseptic practices to ensure safety and quality of the products.
3. Safety
- Comply with all OSHA and plant specific safety policies and procedures at all times, inform management of any safety hazards, and attend all required safety training.
- Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
4. Other Duties
- Collect accurate data for reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making.
- Accurately interpret technical documentation with high attention to detail.
- Assist with executing validation protocols associated with packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state
- Perform other duties as assigned by Management

Knowledge, Experience, and Skills:
- High School Diploma or GED
- Minimum of 2 years in a regulated production/operations environment
- Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.
- Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred. - Knowledge of FDA and/or GMP regulations within production environment preferred.
- Ability to rapidly learn new procedures and reduce them to practice.
- Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 90-day period of working with a trainer.

Other
1. Performs all job functions and responsibilities in a safe and responsible manner.
2. Ability to regularly climb stairs to perform work.
3. Ability to operate motorized pallet jacks.
4. May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials.
5. May be exposed to strong odors incurred during media production or other operations.
6. Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat. Make-up and jewelry are prohibited in certain areas of Manufacturing.
7. Ability to maintain reliable and punctual attendance.
8. May be asked to cross train and support activities in other areas of production.
9. Ability to work overtime as required to support production operation.

About the company

Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.

Notice

Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at [e-mail] or 407-000-0000.

Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.

An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at [e-mail] or 407-000-0000.