Lead Specialist - Operations Training (Nights)

About the role

The Operations Training Specialist supports start-up activities required to bring the area into service, focusing on aseptic isolator barrier filling. They will become experts in their assigned area, educating their team on facility operation and creating training programs for Parenteral operations (Filling).

Responsibilities

• Develop and administer technical training for operations personnel.
• Coordinate daily on-the-job training for shifts.
• Evaluate On-the-Job Training for qualification.
• Coordinate one-off training for individuals returning from Leave of Absence.
• Author revisions for Operations Standard Operating Procedures (SOPs).
• Assist with periodic reviews of SOPs and other training materials.
• Act as a delegate in Success Factors (track training completion).
• Work with network partners to implement best practices.
• Serve as an Operations Subject Matter Expert (SME) during area tours.

Requirements

• High School Diploma or GED.
• Effective communication (written and verbal).
• Computer proficiency (desktop software, MS Office).

Preferred Attributes

• STEM degree or certifications.
• Previous experience in a formalized teaching or training environment.
• Experience in operations or manufacturing environments.
• Knowledge of current Good Manufacturing Practices (CGMPs).
• Experience with aseptic filling, single-use assemblies, isolator technology.
• Experience with Manufacturing Execution Systems and electronic batch release.
• Experience with continuous improvement (Lean, Six Sigma methodologies).
• Leadership and ability to train/educate team members.
• Willingness to travel.