Manufacturing Operator

About the role

This role is responsible for operating pharmaceutical manufacturing equipment in a regulated GMP environment to produce clinical supplies and support development experiments. The manufacturing operator follows established procedures, maintains high-quality documentation, and works closely with quality, maintenance, and development teams to ensure safe, compliant, and efficient production. This is a Contract to Hire position based out of East Windsor, NJ, requiring fully onsite work.

Responsibilities

• Train on and understand all applicable policies and procedures, including regulatory requirements, safety guidelines, standard operating procedures (SOPs), work instructions, and related documentation.
• Perform pharmaceutical manufacturing activities in a GMP or other regulated manufacturing environment, adhering to batch records and Good Documentation Practices (GDP).
• Set up, operate, change over, and clean pharmaceutical manufacturing equipment and rooms according to SOPs and work instructions.
• Execute line setup and line clearance activities to ensure equipment and work areas are properly prepared and documented before production.
• Perform in-process inspections and sampling to verify product quality and process performance, documenting results accurately and in a timely manner.
• Use appropriate personal safety equipment and engineering controls to protect personnel, products, and equipment.
• Operate within an IT platform to enter, review, and track production data and related documentation.
• Perform developmental manufacturing experiments under the direction of a formulation specialist or process engineer to support process development and optimization.
• Support investigational and quality systems activities, including deviation support, corrective actions, and continuous quality improvement initiatives.
• Assist maintenance personnel with preventive maintenance activities, basic troubleshooting, and repair support for manufacturing equipment.
• Participate in continuous improvement activities by making suggestions for process, safety, or efficiency enhancements and by adopting new skills and procedures.
• Carry out all duties in compliance with applicable federal and state regulations, guidelines, and internal company and site policies.
• Remain current with industry trends and professional best practices relevant to pharmaceutical manufacturing and GMP operations.
• Complete required regulatory and job-specific training and maintain training records in good standing.
• Perform repetitive tasks while maintaining production speed, accuracy, and attention to detail.
• Work effectively as part of a team, collaborating with colleagues in production, quality, engineering, and other functions.
• Be available for additional duties as required and for overtime as needed to meet production and project timelines.

Requirements

• Associates degree and at least 2 years of experience in GMP pharmaceutical manufacturing, research and development, or pharmaceutical equipment manufacturing.
• Experience working in a GMP or regulated manufacturing environment with a strong understanding of compliance and quality expectations.
• Hands-on experience with batch records and Good Documentation Practices (GDP), including batch record review and accurate documentation of manufacturing activities.
• At least 2 years of experience in batch record review, quality assurance operations, and line clearance activities.
• Pharmaceutical or contract development and manufacturing organization (CDMO) GMP experience in production or chemical manufacturing involving equipment operation and SOP-driven processes.
• Knowledge of current Good Manufacturing Practices (cG