Supervisor, Manufacturing - Filling (Nights)

Job Responsibilities

• Provides direction to PET personnel in the efficient use of equipment and materials to produce quality products in accordance with regulations.
• Responsible for all PET activity to include coordination of support staff, scheduling and improvement.
• Promotes the use of safe work practices during all aspects of production and ensures all external and internal EHS standards are met daily.
• Accountable for training of PET personnel on equipment, processes and Standard Operating Procedures. Partners with PET Coach to develop training plans and assist in providing resources for training.
• Ensures that cGMP’s are used and followed during production of products so that all FDA and international regulations are met. Responds to monthly internal audit observations.
• Promotes a positive work environment by effectively administering Human Resources policies and procedures including Performance Management and by communicating information to employees and responding to their concerns.
• Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs and so on.
• Generates reports for deviations, assists in the investigations, and recommends/implements solutions to resolve deviations. Approves deviation investigations as appropriate. Responds to product defect notifications.
• Authors, reviews, and approves Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
• Promotes and encourages continuous improvement in efficiency, quality, production, and safety using team driven processes and key performance indicators and recognition and rewarding high performance.
• Collaborates with OE Engineers & PET Engineers to optimize process performance.
• Participates in the design, selection, installation and qualification of new equipment, facilities, and processes.
• Provides career development and performance management for direct reports.
• Works collaboratively within and across PETs to ensure flow of product, sharing of best practices and lean behaviours.
• Maintains presence across multiple shifts.
• Occasionally performs rolls for PET Lead when designated.

Minimum Requirements

• Prior experience in production environment.
• Previous leadership experience leading direct reports.
• Communication and leadership skills.
• Problem solving skills.
• Demonstrated understanding of how technical documentation (SOPs, batch records, work instructions) is written and used in a production environment.

Preferred Background

• Bachelor of Science in Engineering, Pharmacy, related Science or business.
• Experience working in a LEAN manufacturing environment.
• Working knowledge of LDMS or Veeva, Microsoft applications, SAP.
• Experience working in SAP, particularly production orders, inventory movements, and confirmations related to filling operations.
• Training or experience in formulation, filling, packaging, validation, technology transfer, change control.
• Knowledge or previous experience with pharmaceutical manufacturing, aseptic filling preferred.
• Strong mechanical, troubleshooting, and problem-solving abilities.
• Ability to direct and participate in cross-functional team.
• Project management skills
• Ability to work effectively in a team environment.
• Candidate should possess the ability to work in a changing/demanding environment.