Lead - Filling Operator (Nights)

Role Summary

Lead Operator for filling and isolator operations in a pharmaceutical manufacturing environment. During project startup, you will support area startup activities, equipment setup, isolator filling, and procedure development, and you will train staff to operate the facility. After startup, you will ensure a continuous supply of medicines by expertly running the process, troubleshooting, and collaborating cross-functionally, while maintaining a safety-first and quality-first mindset, coordinating daily activities to meet capacity plans and developing the team’s capabilities.

Responsibilities

• Provide leadership on the manufacturing floor to maintain safety, quality, and productivity and ensure reliable supply of products to patients.
• Maintain a safe work environment, exemplify safe practices, and support health, safety, and environmental goals.
• Act as administrator and technical leader for operations, setting a good example through knowledge of procedures, quality systems, and teaching proper techniques.
• Serve as the primary resource for troubleshooting and escalation on the production floor; mentor operators and train staff as required.
• Operate equipment and perform activities to meet the production schedule; assist in checking execution documentation (Electronic Batch Records, SAP, Cleaning Logs).
• Drive departmental objectives such as improving safety performance, reducing deviations, increasing productivity, and ensuring training compliance.
• Support site leadership to build a diverse and capable site organization by delivering area procedures, quality processes, and controls for isolator operations.
• Assist the Supervisor in development and performance evaluations of shift operators and act as backup when needed.
• Serve as a liaison between operations and support functions (Maintenance, Engineering, TS/MS, Quality).

Qualifications

• Required: High School Diploma or equivalent
• Required: Minimum 2 years of relevant experience in pharmaceutical or medical device manufacturing
• Required: Basic digital literacy
• Required: Knowledge of current Good Manufacturing Practices (cGMPs)
• Required: Legally authorized to work in the United States (no visa sponsorship anticipated)
• Required: Ability to work 12-hour shifts (2-2-3 schedule) with additional overtime
• Required: Must be able to lift 45 lbs
• Preferred: Previous experience working in a Grade C environment with isolator equipment
• Preferred: Participation in media fill qualifications
• Preferred: Scientific/technical degrees or certifications
• Preferred: Previous experience using solution filling equipment and/or isolator technology
• Preferred: Previous experience with Manufacturing Execution Systems
• Preferred: Flexibility to support a major capital project with an aggressive delivery schedule
• Preferred: Knowledge of lean manufacturing principles
• Preferred: High level of attention to detail
• Preferred: Ability to troubleshoot and escalate issues as necessary on the production floor

Skills

• Troubleshooting and escalation on the production floor
• Technical training and coaching of operators
• Operational leadership and ability to coordinate daily activities to meet capacity plans
• Cross-functional collaboration with Maintenance, Engineering, TS/MS, and Quality
• Documentation review and adherence to manufacturing records and logs

Education

• Scientific/technical degrees or certifications (Preferred)

Additional Requirements

• Physical Demands: Must be able to lift 45 lbs