Manufacturing Support Associate 3
Job Description
Lead operational readiness initiatives to prepare people, processes, equipment, and systems for start-up.
Lead site commissioning and qualification efforts to ensure facilities and equipment are ready for compliant use.
Lead troubleshooting in assigned process areas, acting as a process subject matter expert to resolve issues, prevent recurrence, and minimize downtime.
Cook up batch planning, including creating process templates and importing and managing preventive maintenance plans.
Recommend and perform documentation updates to keep records accurate, current, and aligned with process improvements.
Initiate and support training and onboarding; develop, manage, and improve curricula that build consistent capability across shifts.
Cook up non-batch activities and create associated documentation for changeovers, preventive maintenance, and column packing.
Support technology transfer, ensuring seamless introduction and scale-up of processes within manufacturing.
Initiate or support change management records, investigations, corrective and preventive actions, and continuous improvement activities.
Identify and drive highly technical improvement projects in drug substance manufacturing to enhance reliability, yield, and throughput.
Support inspections and audits by preparing and providing required manufacturing documents and evidence of compliance.
Perform other duties, as assigned, to meet production, quality, and safety goals.
Hands-on Equipment Responsibilities
Operate advanced machinery used in production, including assembly lines, presses, and related equipment, to meet quality standards and production targets.
Set up and fine-tune machines, monitor production processes, and troubleshoot moderately complex technical issues; promptly alert colleagues of more complex issues or suspected faults.
Maintain accurate, timely production records and strictly follow all safety regulations and procedures.
Knowledge, Skills, And Abilities
Expertise in manufacturing operations with a high degree of troubleshooting ability.
Strong technical experience with batch planning and the creation and maintenance of manufacturing documentation.
Experience supporting audits, leading investigation support activities, and leading continuous improvement projects.
Clear communicator with strong collaboration skills across operations, quality, and engineering.
Organized, detail-focused, and able to prioritize in a dynamic, around-the-clock environment.
Minimum Education And Experience Requirements
A high school diploma with 8 years of related experience; or an associate’s degree with 6 years of direct experience; or a bachelor’s degree with 4 years of direct experience; or equivalent military experience or training.
Preferred Education And Experience
An associate’s or bachelor’s degree, preferably in life sciences or engineering, with BioWorks or BTEC Capstone current Good Manufacturing Practice coursework preferred.