- Perform the duties of operating assigned machinery consisting of servicing machines with materials, monitoring equipment status, reintroduction of materials, manually palletizing finished materials, and assuring a smooth flow of product.
- Be able to start-up machinery including equipment set-up, perform recipe selection and data entry on manufacturing computerized system (SCADA and HMI), make minor adjustments, and perform critical sensor challenges.
- Perform manual packaging tasks as required including hand packaging and rework of in-process and finished material.
- Operate light material handling equipment (motorized and manual pallet jacks, non-motorized lifts) as the need arises to safely move, store or deliver material to the proper location.
- Perform visual quality inspection and sampling of in-process materials. Promptly escalate concerns to Lead and Process Facilitator as needed.
- Perform minor troubleshooting including clearing minor jams and identifying equipment defects. Work collaboratively with technical resources to resolve equipment issues as needed.
- Perform inventory control and reconciliation activities, which may require the use of SAP and WES in a limited role.
- Perform cleaning, housekeeping and line clearance activities for assigned areas to maintain a cGMP environment. This includes assembling, disassembling and sanitizing various packaging equipment.
- Perform batch record and GMP documentation entries. Perform mathematical computation as needed.
- Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls. Report all discrepancies to process facilitator.
- Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety and quality procedures.
Other Responsibilities
- Support lean activities and process improvement work such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
- Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train and conduct evaluations on other team members for training qualifications.
- Review process documents such as operational SOPs, forms and batch records for accuracy. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
- Execute protocols as required as a part of equipment qualification and process validation work
- Be flexible and support other work areas within the department as needed
- Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.
Competencies & Job Requirements:
- Acquire and maintain all required certifications and qualifications for the assigned work area
- Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the department
- Ability to work effectively in a team environment
- Candidate should possess the ability to work in and adapt to a changing/demanding environment
- Some overtime may be required with minimal advance notice to support business needs
Minimum Qualifications:
- Experience in a pharmaceutical or cGMP regulated environment
- Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
- Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.
Preferred Qualifications:
- High school graduate, vocational school graduate or equivalent
- 1 Year of experience in a pharmaceutical or cGMP regulated environment
- Working knowledge of Microsoft applications and SAP
- Prior production experience
- Experience working in a LEAN manufacturing environment
- Knowledge of cGMPs and FDA policies/procedures