Packaging Operator 3- 2nd Shift

The Packaging Operator 3 at the Ewing site will stage, fill, cap, label, and over pack liquid, powder, and lyophilized products per approved packaging specifications and according to safety and quality protocols. Job duties include: 2nd Shift hours: 1:30 pm - 12:00am, Monday - Thursday.Complete appropriate packaging documentation per FDA, ISO, and GMP procedures and deliver products to inventory.Lead/coordinate filling of complex custom fills.Set up and operate semi-automated and automated equipment.Fill, cap, and label chemical products manually or using automated and semi-automated equipment.Troubleshoot semi-automated and automated filling equipment and processes and escalate issues as necessary to minimize downtime.Fill products utilizing aseptic techniques and/or environmentally controlled areas. Transfer bulk material utilizing peristaltic pumps. Filter bulk material using pumps and in-line filters or vacuum filters. Assist with loading bottles and pack-off during fill line operations.Develop and assist in the implementation of process improvement ideas. Comply with the requirements of ISO 13485 and ISO 9001. Participate in 6S activities.Assist in performing instrument qualifications, operation qualifications, and validations.Assist in writing and updating equipment specific OPs.Train operators on automated and semi-automated equipmentMaintain good housekeeping and audit readiness. Who You Are: Minimal Qualifications: High School diploma or GED.6 + months of chemical weighing, laboratory, filling, or packaging experience.6 + months of experience with automated fill lines or semi-automated filling equipment. Preferred Qualifications: 12+ months of chemical packaging, manufacturing, or scientific/laboratory experience.12+ months of experience in ISO/GMP regulated environment.Proficient in basic math-including metrics and conversions.Knowledge of safety rules, GMP, SOP's, UOP's.Mechanical skills with ability to use pumps, electronic balances, and material handling equipment.Troubleshoot automated packaging equipment.Strong written and communication skills and Effective problem-solving skills.Experience training employees and working in a team setting.