Company Overview
Headquartered in Pomona, California, Med-Pharmex, Inc. is among the leading developers and manufacturers of generic veterinary pharmaceutical products in the U.S. The Company markets over 25 FDA-approved products, all manufactured in one of its three FDA-approved, Pomona-based facilities, with multiple drug delivery systems such as injectables, suspensions, oral solutions, sprays, ointments, creams, pastes, and powders. Utilizing its expertise and experience in pharmaceutical product development in a cGMP environment, the Company’s strength lies in its ability to continually innovate and develop products with high barrier entry, successfully navigate FDA regulatory requirements, and bring quality generic drug products to the veterinary market.
Job Purpose
Med-Pharmex, Inc. is seeking an experienced Automation Engineer to join our team in Pomona, CA. We are looking for someone who is dependable and experienced in maintaining and troubleshooting of system controls in pharmaceutical filling and packing equipment in a cGMP environment.
Key Responsibilities
- Perform installation, preventive maintenance, troubleshooting and repair of all automation systems controls in pharmaceutical manufacturing facility for process, filling and packaging equipment including steam sterilizers.
- Perform inspections and determine the reparability of the automation systems and schedule repairs as needed.
- Responsible for preparing and reviewing technical specifications for hardware and software for new automated systems
- Initiating change controls for installation or modification of the equipment control systems and writing User Requirement Specifications.
- Provide technical support in validation of the control systems.
- Responsible for managing inventory of spare parts required for the equipment controls and maintain the storage of the equipment PLC programs.
- Communicate with the engineering department and document all the troubleshooting/repair and repair activities following the current procedures.
- Comply with the company policies and all safety requirements.
Key Performance Indicators
- Experience with repair of system controls for filling and packaging equipment used in cGMP environment.
- Ability to understand electrical and pneumatic controls used in filling and packing equipment.
- Working knowledge of Microsoft Excel and Word.
- Experience documenting repairs and maintenance in accordance with cGMP requirements.
- Understanding of FDA regulations for computerized system and 21 CFR Part 11 Compliance
- Strong knowledge of basic safety policies and procedures in a manufacturing environment, including gowning and PPE requirements.
- Experience in installation and programming new and older types of Allen Bradley and Siemens PLC including HMI units.
- Must be available to work Monday through Friday.
Competencies
| Problem Solving | Business Fundamentals |
| Engineering & Technology | Safety Awareness |
| Ethics | Mathematical |
| Power Tool Knowledge | Technical |
Person Specification
| Essential | Desirable | |
| Behaviour and Values | Committed to delivering excellence Enthusiastic and results driven Able to take calculated risks Honest with a high level of integrity Team player Willing and able to go the extra mile | |
| Skills | Analytical and Problem Solving | |
| Qualifications | A bachelor’s degree in engineering, computer science or related discipline is required. | |
| Knowledge and Experience | Minimum 5 years of practical experience as automation or system controls engineer for machinery in a pharmaceutical setting. |
Additional Details
When required, must be available to work 6 a.m. to 2:30 p.m., occasional Saturdays, and overtime as needed.
Med-Pharmex is an equal opportunity employer and prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender (including gender identity and gender expression), medical condition, genetic information, marital status, national origin, mental and physical disability, military and veteran status, or any other characteristic protected by law.
