Manufacturing Technician II, DAP (Nights)

Resilience•West Chester, OH

13d•$22 - $32

About The Position

This position requires working in various Controlled/Non-Classified areas. The Manufacturing Technician II operates equipment such as parts washers and autoclave, inspects, cleans, and sterilizes equipment, assembles/disassembles equipment, performs area cleanings in accordance with cleaning schedule, and completes batch record entries. This a Night Shift position working 6:30pm - 6am. 2 days on, 2 days off, 3 days on, 3 days off and the rotation starts over again.

Requirements

Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language
Good attention to detail is required.
The individual must be capable of keeping accurate records and performing mathematical calculations

Nice To Haves

High school graduate, vocational school graduate, or equivalent
Experience in a pharmaceutical or cGMP-regulated environment
Knowledge of cGMPs and FDA policies/procedures

Responsibilities

Perform the duties of operating assigned machinery consisting of parts washers and autoclaves, etc.
Responsible for assembling, disassembling, wrapping, operating, and rinsing/sanitizing various equipment.
Perform set-up activities including but not limited to cleaning/stocking of area, spraying items through airlock, setting up parts wash and autoclave loads per SOP/Form.
Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
Perform visual inspections of equipment for cleanliness as specified per SOP. Must obtain visual inspection training certification.
Obtain knowledge to be able to print off SOP’s/Forms via ECMS.
Perform batch record and GMP documentation entries. Maintain records and/or logs as required to perform job responsibilities. This will include mathematical computation where needed.
Knowledge of product security controls and material handling equipment.
Become aseptically qualified to enter the aseptic core area to unload autoclaves and component processing.
Responsible for outgoing quality level.
Obtain a novice to intermediate level of knowledge of SAP inventory movements and inventory management, such as moving items from one storage location to another and issuing goods to process orders as required.
Responsibly perform work requirements, in accordance with SOPs, cGMPs, and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with “Material Safety Data Sheets” for area chemicals.
Be familiar with job-related safety procedures and hazards, including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to the Area Manager.
Send out pass-down communications as required.
May be required to become media qualified to assist with production activities in other functional areas.
May be required to obtain cold room training/access to be able to transfer materials in and out of the cold rooms.
May be required to take proper training to become a certified trainer within the area.