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Packaging Operations Specialist II

2 months ago

Chester Springs, Pennsylvania, United States National Resilience Full time

A career at National Resilience is more than just a job – it's an opportunity to change the future.

National Resilience is a technology-driven biomanufacturing organization that is transforming the production of medicine. We are establishing a sustainable network of advanced, comprehensive manufacturing solutions to better withstand disruptive events, support scientific innovation, and reach those in need.

Position Overview

The Packaging Operations Specialist is a hands-on role reporting to a Manager/Supervisor on the Manufacturing floor, dedicated to supporting Packaging operations. This position involves working in various Controlled/Non-Classified environments. The Packaging Operations Specialist executes a range of manufacturing tasks including operating machinery, conducting in-process monitoring, performing line clearances, conducting cosmetic inspections, cleaning, and completing batch record entries. Additionally, this role supports continuous improvement initiatives such as 5S, engaging in problem-solving, and participating in Kaizen events to achieve a high standard of purity, quality, and consistency in product output in compliance with cGMPs.

Key Responsibilities
  • Operate assigned machinery, ensuring a smooth flow of product by servicing machines with materials, monitoring equipment status, and manually palletizing finished goods.
  • Initiate machinery start-up, including equipment setup, recipe selection, and data entry on manufacturing computerized systems (SCADA and HMI), while making minor adjustments and performing critical sensor challenges.
  • Carry out manual packaging tasks as needed, including hand packaging and reworking in-process and finished materials.
  • Utilize light material handling equipment (motorized and manual pallet jacks, non-motorized lifts) to safely move, store, or deliver materials as required.
  • Conduct visual quality inspections and sampling of in-process materials, promptly escalating concerns to the Lead and Process Facilitator.
  • Perform minor troubleshooting by clearing minor jams and identifying equipment defects, collaborating with technical resources to resolve issues.
  • Engage in inventory control and reconciliation activities, utilizing SAP and WES in a limited capacity.
  • Maintain cleanliness and organization in assigned areas to uphold a cGMP environment, including the assembly, disassembly, and sanitization of various packaging equipment.
  • Complete batch record and GMP documentation entries, including necessary mathematical computations.
  • Familiarize with job-related safety procedures and hazards, including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls, reporting discrepancies to the process facilitator.
  • Execute work responsibilities responsibly, adhering to SOPs, cGMPs, and established safety and quality protocols.
Additional Responsibilities
  • Support lean initiatives and process improvement efforts by performing 5S in the work area, participating in problem-solving, and manually tracking performance data for OEE and process improvement analysis.
  • Act as a certified on-the-job trainer for team members on assigned equipment and process tasks, conducting evaluations for training qualifications.
  • Review process documentation such as operational SOPs, forms, and batch records for accuracy, suggesting process improvements while ensuring quality and cGMP compliance.
  • Execute protocols as required for equipment qualification and process validation.
  • Be adaptable and support other work areas within the department as necessary.
  • Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee.
Minimum Qualifications
  • Experience in a pharmaceutical or cGMP regulated environment.
  • Proficient in understanding, reading, writing, and communicating in the English language.
  • Strong attention to detail, capable of maintaining accurate records and performing mathematical calculations.
  • Able to acquire and maintain all required certifications and qualifications for the assigned work area.
  • Motivated to learn new skills and develop capabilities continuously to contribute to departmental success.
  • Ability to work effectively in a team-oriented environment.
  • Adaptable to a changing and demanding work environment.
  • Willingness to work overtime as needed with minimal advance notice to support business requirements.
Preferred Qualifications
  • High school diploma, vocational school graduate, or equivalent.
  • One year of experience in a pharmaceutical or cGMP regulated environment.
  • Familiarity with Microsoft applications and SAP.
  • Prior experience in production.
  • Experience in a LEAN packaging environment.
  • Knowledge of cGMPs and FDA policies/procedures.

National Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, protected veteran status, disability status, or any other characteristic protected by applicable federal, state, and local laws.

National Resilience offers a comprehensive total rewards program, including equity, an annual cash bonus program, a 401(k) plan with a generous company match, and a benefits package designed to support employees with excellent healthcare (including medical, dental, and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, and tuition reimbursement.