Manufacturing Equipment Operator - B Shift

JOB SUMMARY: The Manufacturing Equipment Operator is responsible for manufacturing pharmaceutical batches by setting up, cleaning, operating, and maintaining equipment. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Equipment Operator is expected to fully participate in both departmental projects and any quality working teams that may be applicable. This position shall be responsible for the hands-on execution of activities as they relate to the manufacturing or packaging of products. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and complete documentation on all activities. Responsible for monitoring and maintaining quality of product and processes. Will require working with other Associates to minimize downtime during startup process. Perform, and verify, integrity of sterilizing grade filters used in product transfers. Requires working in a classified area (ISO 7) while dressed in clean room gown for extended periods of time. Must be able to obtain, and maintain, clean room gowning certification. When manufacturing batch, manufacturing associates are to abide by good clean room techniques. Will use, and troubleshoot, Supervisory Control Systems during manufacture of batches; these are heavily automated systems used for batch processing and cleaning and steaming of tanks and transfer lines. Ability to sample pH readings and perform titrations. Attention to detail is critical as an oversight can compromise the sterility of a batch. Performs integrity testing of sterilizing grade air and product filters using bubble point and diffusion testing methods. ESSENTIAL FUNCTIONS / RESPONSIBILITIES: Room Process Ready for Production Run (25%) •Prepares for production by reviewing the production schedule, understanding deliverables, and reviewing applicable SOP’s, and any procedure changes. •Ensures that supplies, materials and documents are available as required to meet the production schedule. •Works with other departments to ensure adherence to production schedule. •Receives and distributes supplies into production area, as necessary. •Executes equipment qualification protocols and validation protocols. Product Ready for Further Processing (25%) •Operates general production equipment ensuring its proper operation and adhering to production procedures. •Monitors and records critical process parameters. •Documents production by completing forms, reports, logs and records of equipment and batches. •Keeps equipment operating by following operating instructions, troubleshooting breakdowns, and placing work orders for repairs. Elevates issues when work orders are placed. •Provides input regarding opportunities for improvement, waste reduction, etc. to supervision and/or during team meetings. •Supports implementation of process improvement efforts, cycle time reductions, waste reductions, etc. Equipment Room Ready for Next Production Run (25%) •Prepares equipment for next run by performing cleaning. This may include manually cleaning portable equipment and small parts. •Performs routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion. •Ensures equipment conditions are acceptable to pass to incoming shifts. Communicates any ongoing equipment, material or quality concerns to incoming teams as well as his/her supervisor. •Ensures all paperwork is completed thoroughly and accurately prior to the end of the shift. Safe Work Environment (25%) •Follows all HSSE rules and regulations. Accepts accountability for own personal safety and identifies potential unsafe conditions to help prevent self and co-workers from being injured. •Complies with all site security requirements. Ensures that actions do not create a negative impact on the environment.