Lead, Manufacturing ​/ Production, Operations Engineer

Shift Lead

The Shift Lead oversees day-to-day manufacturing floor operations within a regulated cGMP environment, ensuring safety, quality, and production requirements are met across crosslink and aseptic manufacturing activities. In this role, you serve as the primary on-shift technical resource and lead operator for executing scheduled production activities and maintaining compliance and product quality standards.

• Provides direct floor leadership for assigned manufacturing staff during shift operations, ensuring safe, compliant, and efficient execution of production activities.
• Coordinates and executes daily crosslink manufacturing operations, including organic synthesis, purification, dissolution, formulation, filling, and syringe sterilization within controlled cleanroom environments.
• Assigns and prioritizes work for shift team members.
• Resolves real-time production issues to maintain schedule adherence and operational flow.
• Collaborates with Area Supervisors, Technical Leads, and Engineering to ensure alignment with production schedules and on-time product delivery.
• Ensures timely and accurate completion of all MRP and ERP transactions.
• Executes material receipt, consumption, and production reporting activities in ERP systems.
• Reviews and verifies GMP documentation, including batch records, logbooks, and forms, for accuracy, completeness, and compliance prior to quality submission.
• Monitors material usage, floor inventory, and production readiness.
• Communicates schedule changes and supply needs to the team.
• Ensures compliance with FDA cGMP, ISO standards, OSHA regulations, and EPA requirements across all shift operations.
• Initiates deviations, investigations, and quality events as needed.
• Partners with cross-functional teams to determine root cause and corrective actions.
• Ensures adherence to good documentation practices (GDP).
• Maintains data integrity across all manufacturing records.
• Supports training and development of junior staff by identifying skill gaps.
• Conducts on-the-job training for operators and technicians.
• Provides performance feedback to supervisors and team members.
• Acts as a subject matter expert for critical manufacturing processes.
• Performs hands-on execution of critical process steps when required.
• Ensures safe work practices across the shift.
• Escalates safety concerns or risks to management in a timely manner.
• Performs other duties and projects as assigned.

This role functions as the on-shift operational leader responsible for coordinating manufacturing activities, maintaining compliance, and ensuring production targets are achieved in a highly regulated environment. The Shift Lead must make real-time decisions that impact safety, quality, and delivery performance. The role requires strong technical knowledge, situational awareness, and the ability to guide and support a team in a fast-paced manufacturing setting where errors can result in compliance risks, production delays, or quality issues.

• Bachelor's degree in Engineering, Chemistry, Manufacturing, or related technical discipline preferred, or equivalent relevant experience.
• Minimum of 6 years of experience in cGMP manufacturing environments.
• At least 3 years of experience using Material Requirements Planning (MRP) systems, including production transactions and material tracking.
• Minimum of 2 years of experience in a cGMP-regulated pharmaceutical or medical device manufacturing Lead or similar role, including training or mentoring operators.
• Strong understanding of FDA, ISO, OSHA, and other applicable regulatory and quality system requirements.
• Strong verbal and written communication skills with the ability to effectively coordinate team activities on shift.
• Ability to work flexible hours to support production requirements.

• Experience supporting internal audits, inspections, or quality system assessments.
• Experience working in cleanroom environments and/or using aseptic technique.
• Experience using SAP or similar ERP systems for manufacturing transactions and reporting.
• Proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint).
• Strong…