Role Summary
Supervisor - Aseptic Filling (Day Shift) leads the Parenteral (PAR) filling operations team during startup and after turnover to manufacturing. The role oversees start-up activities, training, and operational readiness for the PAR area, then manages multiple PAR departments with a focus on safety, quality, and staff development. Travel is required domestically (2–4 week trips and/or 3–12 month assignments) with potential international collaboration. This position offers growth into broader leadership and technical roles within the site.
Responsibilities
- Lead by example with a Safety First, Quality Always mindset; promote Stop Work Authority when safety or product quality is at risk.
- Maintain a safe work environment and support health, safety, and environmental goals.
- Serve as administrator and technical leader for operations; model adherence to procedures and quality systems.
- Collaborate with area supervisors to sustain high standards of communication, best practice sharing, and consistency across shifts.
- Oversee shop floor execution to meet production plans, cGMP conformance, and Manufacturing Excellence standards.
- Promote continuous improvement by gathering improvements, articulating their value, and implementing high-value ideas.
- Ensure adequate, trained, and compliant personnel staffing to meet production goals; maintain and update training plans.
- Develop area documentation (procedures, work instructions, job aides) to support startup, training, and operation.
- Originate and investigate deviations and quality issues; support root cause analysis and corrective actions.
- Build a diverse, empowered, and capable team; coach, develop, and evaluate operators.
- Communicate cross-functionally with support teams regarding quality, equipment, and operational concerns.
Qualifications
- Required: High School Diploma or equivalent
- Required: Prior supervisory experience
- Required: Basic computer skills (desktop software, MS Office)
- Required: Experience in operations or directly supporting a manufacturing operation (Pharma, Food, Clean-room, or other applicable)
- Required: Excellent interpersonal, written, and oral communication skills
- Required: Strong organizational skills and ability to prioritize multiple requests
- Required: Strong technical aptitude and ability to train and mentor others
- Required: Valid driver's license
- Preferred: 4+ years in manufacturing/operations with 2+ years in supervisory role
- Preferred: cGMP standards and FDA (or other industry) guidelines for production
- Preferred: STEM degree or certification
- Preferred: Aseptic filling, single-use assemblies, isolator technology
- Preferred: Automated, semi-automated, and/or manual inspection
- Preferred: Highly automated equipment (inspection, packaging, filling, assembly, etc.)
- Preferred: Manufacturing Execution Systems and SAP or other electronic business systems
- Preferred: Continuous improvement methodologies (lean, six sigma, etc.)
- Preferred: Root cause analysis and corrective actions implementation
- Preferred: Ability to organize and motivate teams
- Preferred: Facility, Equipment, Systems, Startup experience
Additional Requirements
- Ability to work overtime as required
- Willingness to work a 12-hour day shift (6am–6pm on a 2-2-3 schedule)
- Ability to wear necessary safety equipment and gown in a cleanroom (Grade C, ISO 8)
- Potential short-term domestic or international assignments (3–12 months) to train and certify on processes
- Eligibility to work in the United States; sponsorship may not be provided