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Role Summary
Manufacturing Process Technician - 3rd Shift (8 hour)
Responsibilities
Following Good Manufacturing Practices (GMPs) and applicable regulations from the Code of Federal Regulations (CFRs).
Reporting any discrepancies to the Line Leader or Manufacturing Manager to ensure quality standards and safety.
Ensuring quality & compliance through a Right First-Time mentality.
Receiving and preparing components for use in manufacturing.
Feeding components into equipment and performing sanitation activities.
Documenting appropriate paperwork, understanding Overall Equipment Effectiveness (OEE)/performance metrics, and participating in daily performance meetings.
Use of pallet jacks and manual wrapping of pallets.
Use of computer systems to support material inventory and electronic batch records.
Partnering with cross-functional teams to drive improvement opportunities.
Ensuring components and products are available for continuous operation.
Qualifications
Required: High school diploma / GED and 1 year of Manufacturing or Operations experience
Or: Associate’s degree
Preferred: 1+ years of experience in a GMP/ regulated environment
Demonstrated knowledge of GMP principles
Experience in a drug product manufacturing environment
Ability to assemble, disassemble, operate and understand simple to moderately complex equipment per procedures
Basic understanding of measurements, calculations, and the metric system
Ability to work in individual and team settings, with small groups and cross-functional teams to troubleshoot issues and implement corrective actions
Ability to use computer systems to document electronic batch records
Coachable and able to take critique and show measurable improvement
Capacity to follow written procedures, recognize and report malfunctions
Strong written and verbal communication
Ability to perform assignments with high focus and attention to detail
Available to support operations in non-standard shifts that include weekends and/or holidays as determined by the business
Skills
Machine operation and troubleshooting
Documentation and electronic batch records
Cross-functional collaboration
Quality and compliance mindset
Attention to detail and problem-solving
Education
High school diploma or GED; or Associate’s degree