ATL02-101024 - Manufacturing Operator - Tableting - Validation & Engineering Group

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Manufacturing Operator

Job Summary:
The Manufacturing Operator will be responsible for the production, packaging, and inspection of solid dosage products, primarily tablets, in a highly regulated, FDA-compliant manufacturing environment. The role requires strict adherence to cGMP (current Good Manufacturing Practices), SOPs (Standard Operating Procedures), and quality standards to ensure product safety, efficacy, and compliance with regulatory requirements.

Key Responsibilities:

• Operate, monitor, and troubleshoot machinery for the manufacturing and packaging of solid dosage forms (tablets), including granulation, blending, compression, and coating processes.
• Follow approved batch records, SOPs, and cGMP guidelines to ensure product quality and consistency.
• Perform in-process checks and sampling to verify product specifications, such as weight, hardness, and disintegration, are met during manufacturing.
• Set up, adjust, and maintain manufacturing and packaging equipment to ensure efficient and consistent operations.
• Ensure cleanliness and proper sanitation of equipment and production areas as per SOPs and FDA requirements.
• Accurately complete all required documentation, including batch records, equipment logs, and maintenance records.
• Collaborate with the Quality Assurance and Quality Control teams to resolve any deviations, product quality issues, or equipment malfunctions.
• Participate in continuous improvement initiatives to enhance productivity, reduce waste, and maintain compliance with all safety and regulatory standards.
• Ensure packaging operations meet FDA standards for labeling, lot control, and packaging integrity.
• Conduct line clearance and inspections to confirm cleanliness and readiness for production.

Qualifications:

• High school diploma or equivalent; technical training in a related field is a plus.
• Minimum of 5 years of experience in pharmaceutical or FDA-regulated manufacturing, specifically in the production of solid dosage forms (preferably tablets).
• Strong understanding of cGMP, FDA regulations, and pharmaceutical manufacturing processes.
• Hands-on experience with tablet manufacturing equipment such as granulators, blenders, and tablet presses.
• Excellent attention to detail and ability to follow precise manufacturing and packaging instructions.
• Ability to work in a fast-paced, highly regulated environment while maintaining high-quality standards.
• Good communication skills and ability to work effectively in a team-oriented environment.
• Ability to lift heavy materials, stand for extended periods, and work in a physically demanding production environment.