Manufacturing Specialist 1, Training

What you’ll do

• Support operational readiness initiatives that prepare people, processes, and systems for start-up.
• Support site commissioning and qualification efforts to ensure equipment and facilities are ready for compliant use.
• Coordinate batch planning, including creating process templates and importing/managing preventive maintenance activities.
• Maintain accurate, up-to-date documentation; complete timely updates of records, including redlines and process improvements.
• Care for inventory management and support the use of the enterprise resource planning system (SAP) for efficient manufacturing operations.
• Support technology transfer activities within manufacturing.
• Ensure adherence to safety and compliance procedures across the manufacturing environment.
• Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions, and continuous improvement activities.
• Identify and drive improvement projects in drug substance manufacturing to enhance throughput, reliability, and quality.
• Assist and support inspections and audits by providing complete and accurate documentation; help ensure ongoing compliance across operations.
• Perform other duties as assigned to meet production, quality, and safety goals.

Training Focus

• Create engaging, compliant training content for manufacturing processes, documentation practices, and safety procedures.
• Facilitate effective training sessions and certifications across day and night shifts, including onboarding and upskilling for new processes and improvements.
• Leverage aseptic qualifications training and pharmaceutical best practices to elevate operational performance.

Minimum Qualifications (education And Experience)

• High School Diploma/GED and 10 years of related experience; or Associate’s degree, preferably in life sciences or engineering, with 8 years of direct experience; or Bachelor’s degree, preferably in life sciences or engineering, with 6 years of direct experience; or Equivalent military experience/training.

Preferred Qualifications

• Strong current Good Manufacturing Practice manufacturing operations experience.
• Understanding of the sequence of operations and cadence of activities.
• Prior experience updating and creating manufacturing documents on schedule.
• BioWorks or BTEC Capstone current Good Manufacturing Practice coursework preferred.