Senior Pharmaceutical Packaging Technician - DPI (Filling)

United Therapeutics•Rtp, NC

20h•Onsite

About The Position

The Senior Pharmaceutical Packaging Technician is responsible for the setup, operation, and cleaning of all pharmaceutical packaging equipment in RTP, including filling lines, blister lines, packaging lines, and manual kitting operations. This role supports all packaging and kitting operations at the site under limited supervision, involving performance and documentation of start-up checks, in-process checks, equipment adjustments, yield calculations, and batch reconciliations. The technician ensures operations are completed in full compliance with company SOPs, MBRs, and cGMPs, and that all packaging batch documentation, cleaning records, and labels are complete and accurate. They will also support the start-up and operation of future packaging equipment and activities, including vial labeling, tray-loading and unloading, case-packing, and other assigned equipment operation activities. Additionally, the role involves serving as a line lead, maintaining the schedule for assigned lines by coordinating walk-throughs, line clearances, runs cleans, AQL, etc., and assisting with validation activities of new and upgraded lines and processes. The technician is responsible for inventory management and requesting consumables to ensure adequate supply, and for completing moderately complex troubleshooting of packaging equipment, escalating concerns as needed. They will also assist in revising batch records and SOPs, training new and junior employees, and assisting the management team with packaging tours. Strict compliance with all OSHA and company safety policies is mandatory.

Requirements

H.S. Diploma or General Education Degree (GED)
4+ years of hands-on experience in a pharmaceutical manufacturing, packaging or warehouse environment (will consider commensurate experience and/or combination of education and experience)
Ability to navigate sophisticated HMI control systems on automated pharmaceutical packaging equipment
Experience with GMP documentation requirements and have experience with completing batch packaging records, reading and understanding SOPs, and working with packaging machinery
Basic computer skills required

Nice To Haves

Ability to perform and verify all UT lines
Two years of experience backing up a UT line

Responsibilities

Set up, operation, and cleaning of all pharmaceutical packaging equipment in RTP, including filling lines, blister lines, packaging lines, and manual kitting operations.
Support all packaging and kitting operations at the site under limited supervision.
Perform and document start-up checks, in-process checks, equipment adjustments, yield calculations, and batch reconciliations.
Ensure operations are completed in full compliance with company SOPs, MBRs, and cGMPs.
Ensure all packaging batch documentation, cleaning records, and labels are complete and accurate.
Support the start-up and operation of future packaging equipment and activities under limited supervision, including vial labeling, tray-loading and unloading, case-packing, and other equipment operation activities as assigned.
Serve as a line lead and maintain schedule for assigned line by coordinating walk throughs, line clearances, runs cleans, AQL, etc.
Assist with validation activities of new and upgraded lines and processes.
Inventory and request consumables in order to ensure an adequate supply for packaging.
Complete moderately complex troubleshooting of packaging equipment.
Escalate concerns to Lead Tech and/or Supervisor.
Assist in revising batch records and SOPs as needed.
Assist in the training of new and junior level employees.
Assist management team with packaging tours.
Responsible for strict compliance with all OSHA and company safety policies.