Manufacturing Associate, Lead – Parenteral Filling (Nights)

Role Summary

The Manufacturing Associate, Lead plays a critical hands-on leadership role within a cGMP manufacturing environment, performing and documenting daily manufacturing operations while ensuring compliance, quality, and efficiency. This role works closely with the Manufacturing Supervisor to coordinate shift activities, allocate resources, and support production, validation, and continuous improvement initiatives. Night shift coverage is from 6:00 PM to 6:00 AM on a rotating 2-2-3 schedule.

Responsibilities

• Execute manufacturing processing steps and manufacturing support activities in accordance with batch records, SLRs, control systems, and standard operating procedures.
• Monitor and control processes, serving as a subject matter expert (SME) for assigned unit operations and process steps.
• Coordinate and, as required, lead process steps while ensuring adherence to cGMP requirements.
• Partner with the Supervisor to schedule daily shift activities, plan resource allocation, and support production, validation, and project-related work.
• Ensure effective shift handoffs through clear communication of issues, priorities, and status updates.
• Document, review, and ensure completeness of cGMP documentation including batch production records (BPRs), SLRs, deviations, and equipment logbooks, with real-time review for accuracy and compliance.
• Develop, revise, and maintain cGMP documents as needed.
• Actively participate in training activities, manage individual training plans, and provide hands-on training and knowledge sharing to other associates.
• Observe employee performance, provide timely coaching, and deliver feedback to the Supervisor during mid-year and end-of-year evaluations.
• Initiate and investigate deviations, support root cause analysis, and develop corrective and preventive actions (CAPAs) under Supervisor guidance.
• Lead or participate in troubleshooting efforts and serve as a potential SME during audits.
• Support equipment and facility maintenance activities to ensure operational readiness and compliance.

Qualifications

• Required: Bachelor's degree in Science, Technology, Engineering, or Mathematics (STEM) or related field from an accredited college or university with a minimum of 4 years of direct experience
• Required: Associate’s degree in Science, Technology, Engineering, or Mathematics (STEM) or related field from an accredited institution with a minimum of 4.5 years of direct experience
• Required: High school diploma or equivalent with a minimum of 5 years of direct experience
• Required: Demonstrated experience working in a cGMP manufacturing environment
• Required: Strong documentation, compliance, and process execution skills
• Required: Ability to lead tasks, support teams, and collaborate effectively across shifts
• Preferred: Prior Parenteral Filling experience
• Preferred: Experience with TrackWise, DeltaV, and LIMS systems

Skills

• Process leadership and SME capabilities across multiple unit operations
• Strong documentation and real-time compliance mindset
• Collaboration, coaching, and cross-shift team leadership
• Problem solving, troubleshooting, and CAPA execution
• Familiarity with manufacturing software systems (e.g., TrackWise, DeltaV, LIMS) as applicable

Education

• Bachelor’s degree in Science, Technology, Engineering, or Mathematics (STEM) or related field from an accredited college or university with a minimum of 4 years of direct experience
• Associate’s degree in Science, Technology, Engineering, or Mathematics (STEM) or related field from an accredited institution with a minimum of 4.5 years of direct experience
• High school diploma or equivalent with a minimum of 5 years of direct experience