High Value Production Operator

West Pharmaceutical Services; Kinston (NC); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is seeking dedicated team members to process High Value Products in a clean room environment. This role requires attention to detail and the ability to work collaboratively in a fast-paced setting. Ideal candidates will have experience in cGMP manufacturing and a strong commitment to quality and safety standards. Join a community focused on improving patient lives while enjoying opportunities for growth and development. Your contributions will play a vital role in delivering life-saving products to patients in need.

Benefits

Health insurance

Retirement plan

Paid time off

Employee discounts

Training and development programs

Qualifications

• Minimum 2 years of cGMP manufacturing experience required.
• Must be able to read and write in English.
• Experience in a controlled clean room is preferred.

Responsibilities

• Adhere to gowning requirements for clean room entry.
• Maintain documentation for lot traceability.
• Operate equipment within cGMP standards.

Skills

cGMP manufacturing experience

Attention to detail

Basic computer skills

Teamwork

English proficiency

Education

High School Diploma or GED

Tools

SAP

PC

pharma wash equipment

Job description

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

To work as a team member to process High Value Products (HVP) through the HVP process with minimal assistance from management or engineering. Team members must have the ability to work with other team members in a cell concept rotating through multiple job functions throughout the day following a playbook for optimal performance. Team members must be able to perform job functions with a full gown/goggles in which no skin is visible within the area for multiple hours at a time. Ideal candidates are quick thinking and confident to ensure consistent processing and foresight to know the next task required. It is the responsibility of this individual to ensure that product/customer specifications are followed always. Ideal candidates have previous cGMP experience and have the knowledge of how to operate within a classified clean room.

Schedule: Nights (5:45 PM - 6:00 AM) on 2, 2, 3 schedule

Essential Duties and Responsibilities

• Strictly adhere to all requirements pertaining to gowning for entry into classified clean room areas.
• Candidates must be able to pass gowning qualifications to enter classified clean rooms.
• Accurately maintain all required documentation and paperworkto ensure lot traceability.
• Operate pharma wash equipment and oversee processes within classified clean rooms such as pre-staging, staging, loading, unloading and final packaging, per cGMP standards.
• Strict adherence to product/customer specifications.
• Ensure that weigh/count equipment is set up accurately and within calibration.
• Correctly sample product for QA inspections and pre-delivery samplesin cGMP manner.
• Keep equipment and work area in clean and orderly condition.
• Operate Envision system correctly according to all applicable procedures.
• Operate steam sterilization process including but not limited to start functions such as loading, unloading and packaging.
• Input and log data correctly for the Autoclave process when needed.
• Perform all positive pressure and cleaning requirements for all classified cleanrooms associated with the HVP Processing department.
• Alert the Area Manager to conditions that may prevent meeting production and quality expectations.
• Operate PC, printers and scanners as required.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

Education

• High School Diploma or GED required.

Work Experience

• Minimum 2 years of cGMP manufacturing experience.

Preferred Knowledge, Skills and Abilities

• Must possess an acute attention to detail.
• Basic computer skills, i.e. use a mouse/keyboard.
• Ability to apply Good Manufacturing Practices (GMP)
• General use of computer work station and ability to use SAP commands is preferred.
• Must be willing and able to work as a team member and make general decisions within authorized job responsibilities.
• Must be able to train and guide others as required.
• Must be able to read and write in English.
• Preferred candidate will have experience working in or processing in a controlled clean room and have knowledge of cGMP requirements for controlled environments.

Travel Requirements 5%: Up to 13 business days per year Physical Requirements Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects. Additional Requirements

• Must have corrected or uncorrected vision of 20/30 or better.
• Must pass color vision test.
• Must be able to tolerate industrial odors and smells on a frequent basis.

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.

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