Description:
Essential Duties And Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Responsible for accurately maintaining accurate records, required logs and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.
- Performs and supports daily manufacturing operations inclusive of batch execution, product inspections, setup, operation, disassembly, and cleaning of manufacturing equipment.
- Enter and record production activities in Oracle MRP systems to issue material and labor hours to specific work orders.
- Supports equipment maintenance and troubleshooting activities to minimize process downtime or re-occurrence. Support investigational activities around events/non-conformances or customer complaints.
- Supports equipment evaluations and validation activities associated with the developed manufacturing processes
- Communicate with team members and support teams to ensure continuous production of the correct product at high quality levels with minimal wasted time and materials
- Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
- Interfacing with HMIs.
- Support department and plant Safety goals by continuously demonstrating safe behavior.
- Maintain, analyze problems, troubleshoot, and make adjustments to process equipment as needed and detect when equipment is not operating correctly.
Desired Minimum Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
- High School Diploma or equivalent with 2+ years of experience in the Medical Device industry or Pharmaceutical industry within a clean room environment preferred.
- Must work and collaborate as part of a team.
- Ability to operate, maintain and troubleshoot process equipment, and make adjustments as needed.
- Strong mechanical abilities as applied to an automated production line.
- Must read, write, and speak in English, and communicate clearly and concisely.
TOOLS AND EQUIPMENT USED
- Lyophilizers, homogenizers, HMI, pH meters, balances (scales), Steris Washer, Printers, Crosslink chambers.
- Oracle MRP System