Supervisor - Parenteral Manufacturing Operations 2nd Shift

Responsibilities

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Ensure strict compliance with established policies/procedures (Safety, Production Procedures, Sanitization, Gowning, Etc.), ensure operators are trained appropriately.
• Take ownership for implementation of countermeasures associated with audits, observations, inspection findings, and deviations.
• Participate in planning of equipment prep, formulation, and filling operations. Network with various areas to verify components and equipment are available for orders.
• Actively participate in commissioning and qualification activities as the site prepares for initial manufacturing operations, including equipment walkthroughs, procedure reviews, and operator readiness assessments.
• Partner with cross-functional teams (Engineering, TSMS, Quality, etc.) to support the transition from line ramp-up to routine production.
• Identify and escalate issues to appropriate channels.
• Leads and participates in structured problem-solving (root cause analysis, countermeasure development, etc.) to improve safety, quality, and operational performance.
• Responsible for the coaching, development and performance evaluation of Operations personnel.
• Act as both administrator and technical leader for operations, setting a good example through demonstrated knowledge of procedures, compliance with quality systems and use of proper technique.
• Responsible for shop floor execution as it relates to business plan, GMP conformance, and operational excellence.
• Ensure adherence to use of proper technique in isolator and Grade C operational areas.

Qualifications

• High School Diploma or GED
• 2+ years previous experience in operations or directly supporting a pharmaceutical manufacturing operation
• Strong understanding of FDA guidelines and cGMP requirements