Production Operations Supervisor

The Production Supervisor is responsible for overseeing the timely and compliant manufacturing of parenteral products in an aseptic environment, in accordance with Current Good Manufacturing Practices (cGMP). Key responsibilities include supervising the setup and operation of sterile filling and dehydrogenation equipment, managing filling and capping processes, and overseeing formulation activities.

This role ensures adherence to all applicable regulations and procedures, maintains Current Good Documentation Practices (cGDP), and actively participates in training and continuous improvement initiatives to enhance production efficiency. The supervisor also oversees sanitation of aseptic and controlled areas using specialized equipment and solutions, ensuring compliance with sanitization protocols and Standard Operating Procedures (SOPs).

Essential Duties and Responsibilities:

• Lead and coordinate personnel and production room activities during assigned shifts
• Accurately compile and communicate shift-specific information and line status updates
• Ensure compliance with cGMP, site policies, and procedures
• Track and report performance metrics for the production unit
• Mentor and develop team members, supporting succession planning and cross-training
• Monitor schedule adherence and material usage
• Oversee operational and preventive maintenance of processing equipment
• Report and investigate safety incidents and quality deviations
• Provide leadership coverage in the absence of management
• Collaborate with other production units to share resources as needed
• Lead or support investigations, document updates, protocol development, and CAPA initiatives
• Interpret and follow SOPs to ensure compliance
• Maintain current training records
• Perform other duties as assigned

Education and Experience Requirements:

• Associate's degree in Science, Business, Engineering, or a related field
• Minimum of 3 years of experience in pharmaceutical manufacturing or a related industry
• At least 1 year of experience in a leadership role
• Bachelor's degree in a relevant field with at least 1 year of leadership experience preferred

Supervisory Responsibilities:

This position involves leading a team to meet organizational goals, fostering a positive work environment, providing guidance and support, and evaluating performance to drive continuous improvement and achieve departmental objectives.