High Value Production Operator

RXinsider LTD.

Kinston, Northern (NC, KY)

Hybrid

USD 42,000 - 65,000

Full time

5 days ago
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Benefits offered by this job

Generous PTO
Diversity & inclusion
Tuition assistance
Global career opportunities
Bonuses

Job summary

West Pharmaceutical Services, Inc. seeks a team member to process High Value Products (HVP) in a clean room under cgmp playbooks, with minimal supervision. You will work in a cell-based rotation and must pass gowning qualifications to enter restricted areas.

The role emphasizes precise documentation, adherence to specifications, and safe operation of autoclave, Envision, and wash equipment, with a 12‑hour night shift schedule (2‑2‑3).

Qualifications

  • Gowning qualifications required to enter classified clean rooms.
  • Accurate maintenance of documentation for lot traceability.
  • Operate equipment per cGMP standards and procedures.

Responsibilities

  • Strictly adhere to gowning requirements for clean room entry.
  • Maintain documentation and ensure lot traceability.
  • Operate pharma wash equipment and manage processes in clean rooms.
  • Ensure product/customer specifications are followed at all times.
  • Log data for Autoclave processes and supervise related tasks.

Skills

Detail oriented
Team player
cGMP experience

Education

High School Diploma or GED

Job description

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.

Shift
  • Nights: 12-hr shift on the 2, 2, 3 rotation.
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 paperwork to 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 weight/count equipment is set up accurately and within calibration.
  • Correctly sample product for QA inspections and pre-delivery samples in 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
  • No minimum experience required.
  • 2+ years in cGMP environment or relevant work experience preferred.
Preferred Knowledge, Skills And Abilities
  • Preferred candidate will have experience working in or processing in a controlled clean room and have knowledge of cGMP requirements for controlled environments.
  • Must possess an acute attention to detail and be willing and able to work in a team environment.
  • Make good decisions within authorized job responsibilities.
Travel Requirements

None: No travel required

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.

What We Offer
  • Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
  • Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
  • Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.
  • Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration.
  • Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.
  • Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
  • 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.
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