Senior Pharmaceutical Technician

Catalent•Kansas City, MO

3d•Onsite

About The Position

At Catalent, we don’t just make medicine—we help people live better, longer lives. At the direction of the Supervisor, the Senior Pharmaceutical Technician is responsible for managing and providing direction for efficient set up / tear down, manufacture and cleaning of all equipment and processes associated with manufacturing operations. This role works with functional management, develops specific training requirements focusing on operational specific tasks as well as continued emphasis of FDA cGMP, DEA and Health & Safety regulations, and general work skills as needed. The Senior Pharmaceutical Technician cooperates with Pharmaceutical Manufacturing Leads in the development of instructional material. They are responsible for ensuring cGMP compliance and generally good housekeeping, and ensures 5S standards are met and maintained. The role focuses on driving productivity improvements while maintaining high quality standards. This position serves as a secondary trainer for pharmaceutical technicians within the core group and will also evaluate associates training to identify any gaps or areas for improvement. The Senior Pharmaceutical Technician partners with operational management to standardize training in operations, ensures product is visually inspected to ensure quality requirements are thoroughly met, and supports multiple shift operations. They perform transactions in JDE accurately, provide information to support core group metrics and efficiency increases, and support customer requests as needed. This role drives reductions in unplanned deviations and focuses on troubleshooting identified equipment malfunctions. The Senior Pharmaceutical Technician should have a high ability to troubleshoot and repair equipment. They must be able to wear a PAPR (Powered Air Purifying Respirator) during manufacturing when required and wear required gowning to work in GMP manufacturing areas. This role ensures proper documentation of all batch documents and review and approval of steps performed by other operators. All other duties as assigned.

Requirements

High school diploma or GED and 7+ years of experience with 5+ years in a Pharma or cGMP manufacturing environment required.
Thorough equipment process and framework knowledge.
SQDC leadership.
Process / process scheduling skill.
Thorough knowledge of cGMP, FDA, MHRA and DEA guidelines and how to apply them effectively.
Thorough knowledge of Solid Dosage manufacturing.
Must possess leadership qualities or high potential of team management capability.
Minimum of advanced operator qualification per supervisor / manager specified equipment train(s).
Excellent computer skills.
Able to manage priorities and projects prioritizing effectively.
Must communicate clearly with all levels of management, and manage people well.
Capability to work in a matrix organization.
Demonstrates proficiency in Catalent core competencies per supervisor / manager discretion.
Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day, depending on duration of the shift.

Nice To Haves

Technical degree/certification and 5+ years of experience with 5+ years in a Pharma or cGMP manufacturing environment preferred.

Responsibilities

Managing and providing direction for efficient set up / tear down, manufacture and cleaning of all equipment and processes associated with manufacturing operations.
Developing specific training requirements focusing on operational specific tasks as well as continued emphasis of FDA cGMP, DEA and Health & Safety regulations, and general work skills as needed.
Ensuring cGMP compliance and generally good housekeeping.
Ensuring 5S standards are met and maintained.
Driving productivity improvements while maintaining high quality standards.
Serving as a secondary trainer for pharmaceutical technicians within the core group.
Evaluating associates training to identify any gaps or areas for improvement.
Partnering with operational management to standardize training in operations.
Ensuring product is visually inspected to ensure quality requirements are thoroughly met.
Supporting multiple shift operations.
Performing transactions in JDE accurately.
Providing information to support core group metrics and efficiency increases.
Supporting customer requests as needed.
Driving reductions in unplanned deviations and focusing on troubleshooting identified equipment malfunctions.
Troubleshooting and repairing equipment.
Wearing a PAPR (Powered Air Purifying Respirator) during manufacturing when required.
Wearing required gowning to work in GMP manufacturing areas.
Ensuring proper documentation of all batch documents and review and approval of steps performed by other operators.