Job Title: Manufacturing Operator

Job Description

The Manufacturing Operator works under direct supervision to operate pharmaceutical manufacturing equipment in a cGMP environment, producing clinical supplies and supporting development experiments. This role combines hands-on equipment operation, meticulous documentation, and collaboration with quality, maintenance, and development teams in a fast-growing contract manufacturing setting.

Responsibilities

• Train on and consistently follow 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 while maintaining strict compliance with quality and safety standards.
• Execute batch record activities and maintain Good Documentation Practices (GDP), ensuring all manufacturing data, entries, and corrections are accurate, complete, and legible.
• Set up manufacturing lines, perform changeovers, and operate production and packaging equipment according to established procedures.
• Carry out room and equipment setup, operation, and cleaning for pharmaceutical production, ensuring areas and equipment meet cleanliness and readiness requirements.
• Use appropriate personal protective equipment (PPE) and engineering controls to perform all tasks safely and in accordance with safety policies.
• Conduct in-process inspections and sampling to verify product quality and process performance, documenting results as required.
• Use the designated IT platform and computer systems to enter data, complete electronic records, and support manufacturing and quality processes.
• Perform developmental manufacturing experiments under the direction of a formulation specialist or process engineer, following experimental protocols and documenting outcomes.
• Support investigational and quality systems activities, including assisting with deviations, corrective actions, and continuous improvement initiatives.
• Assist maintenance personnel with preventative maintenance activities, basic troubleshooting, and minor repairs of manufacturing equipment as needed.
• Participate actively in continuous improvement activities by suggesting process enhancements, efficiency gains, and quality improvements.
• Remain current with professional and industry trends, incorporating new knowledge into daily work where appropriate.
• Make positive contributions by offering suggestions for improvement and actively learning new skills, procedures, and processes.
• Carry out duties in full compliance with all applicable federal and state regulations, as well as company and site policies and procedures.
• Remain available for additional duties as required to support production schedules and operational needs.
• Be available for overtime as needed to meet production and project timelines.

Essential Skills

• Associates Degree in a scientific discipline, engineering, or a related field.
• At least 2 years of experience in GMP pharmaceutical manufacturing, research and development (R&D), or pharmaceutical equipment manufacturing.
• 2+ years of experience with batch record review, QA operations, and line clearance in a pharmaceutical or CDMO GMP environment.
• Hands-on experience as a manufacturing operator or packaging technician in a regulated or GMP manufacturing setting.
• Demonstrated experience working within QA and compliance requirements in a pharmaceutical or CDMO production environment.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and their application to daily manufacturing activities.
• Ability to read and interpret standard operating procedures, manuals, batch records, work instructions, and specifications.
• Legible handwriting and the ability to complete detailed written documentation accurately and consistently.
• Clear written and oral communication skills for effective interaction with cross-functional teams and accurate documentation.
• Proficiency with basic arithmetic, including addition, subtraction, fractions, percentages, ratios, and proportions, and the ability to apply these concepts to practical manufacturing tasks.
• Ability to identify simple and moderate problems related to job functions and escalate or resolve them appropriately.
• Demonstrated deductive reasoning skills to apply general rules to specific problems and produce logical solutions.
• Demonstrated inductive reasoning skills to combine pieces of information and identify patterns, trends, or relationships.
• Ability to perform repetitive tasks while ma