Position Summary:

Manufacturing Technician Lead – Vial line will be responsible for providing leadership within the area’s team, owning initiatives, acting as a liaison between operations and functional groups to support event management, change controls, etc. The Manufacturing Lead Technician will also assist the operations team in the day-to-day oversight of the production floor and lead investigations and drive implementation of actions associated with deviations

Essential Duties and Responsibilities:

• Support Site Leadership to build a capable site organization by delivering area operational procedures, quality processes, and controls for the manufacturing areas.

• Monitor and build a strong safety culture.

• Actively leads manufacturing floor operations and drives timelines.

• Fully trained in the escalation process for delays or issues that may arise.

• Participates and/or leads cross-functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root

Cause Analysis (RCA), Failure Modes and Effects Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE)

• Lead training and troubleshooting for operations.

• Assist in OJT tracking to ensure users are up to date on training and qualified to perform operations.

• Work closely with Logistics on the release of orders.

• Work closely with QA on the floor for comment resolution, deviation initiation, troubleshooting, and timelines.

• Understand and influence the manufacturing control strategy for their area.

• Trained as a Deviation Investigator.

• Development and monitoring of metrics for the area.

• Aid in issue resolution, batch/product approvals, and production schedule execution.

• Lead specific activities of the process teams.

• Any other activities as designated by management.

Basic Qualifications and Capabilities:

• High School Diploma or equivalent.

• Experience: 4+ years of Operations or Manufacturing Support in Pharmaceuticals.

Physical Demands and Work Environment:

• Standing and Walking: Ability to stand and walk for extended periods (up to 8–12 hours per shift).

• Manual Dexterity: Frequent use of hands and fingers for handling, operating equipment, and performing precise tasks.

• Lifting and Carrying: Ability to lift, push, or pull up to 50 lbs occasionally and up to 25 lbs frequently.

• Repetitive Motions: Regular bending, stooping, reaching, and twisting during production activities.

• Visual Requirements: Good visual acuity for reading labels, monitoring equipment, and performing inspections.

• Auditory Requirements: Ability to hear alarms, equipment sounds, and verbal instructions in a low-to-moderate noise environment.

• Personal Protective Equipment (PPE): Must wear appropriate PPE (gowning, gloves, safety glasses, masks, etc.) for extended periods.

• Shift Work: May require weekends and overtime based on production schedules.

• Controlled Environment: Work performed in cleanroom or controlled manufacturing areas following strict GMP guidelines.

• Safety Compliance: Strict adherence to safety protocols, gowning procedures, and contamination control measures

Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. The company is an equal opportunity employer, a drug-free workplace, and complies with applicable ADA regulations