Scientist / Engineer in Durham, NC

Job Title: Manufacturing Operator
Job Location: Durham, NC
Duration: Direct Hire/ Full Time ( with Benefits)

Job Description:

• The Manufacturing Operator is responsible for executing all activities related to batch manufacturing and packaging in accordance with established procedures, safety requirements, and quality standards.
• This includes operating and cleaning equipment, conducting in process testing and sampling, performing dispensing activities, supporting calibrations, and troubleshooting machinery as needed.
• The operator also performs verifications using specialized instruments such as calipers and balances to ensure compliance with product specifications.

Manufacturing & Packaging

• Perform batch manufacturing operations according to approved batch records, SOPs, and safety standards.
• Execute pharmaceutical processing (filling, coating, cutting, etc) and packaging processes.
• Verification of dispensed raw / packaging materials as required.
• Conduct in process checks and sampling during manufacturing and packaging stages.

Equipment Cleaning & Maintenance

• Clean and sanitize equipment, tools, and production areas as per Standard Operating Procedures / Protocols.
• Assist with basic maintenance, calibration, and verification activities for production equipment.
• Troubleshoot equipment issues and escalate when needed to minimize downtime.

Quality & Compliance

• Complete all required forms, logs, and documentation accurately and in a timely manner.
• Follow all SOPs, GMP guidelines, and safety procedures.
• Support departmental requests related to developmental, investigative, or quality related activities.

Additional Duties

• Perform packaging and labeling activities as assigned.
• Operate various production equipment safely and efficiently.
• Assist in training new operators when required.
• Perform other duties as assigned by management.
• Make self availability for the cGMP / Hands-On / Classroom trainings and complete all applicable training forms in a timely manner.
• Troubleshooting the manufacturing equipment operational issues as needed.
• Ability to follow detailed written procedures and documentation requirements.
• Basic understanding of mechanical equipment and troubleshooting.
• Strong attention to detail and commitment to quality.
• Ability to work independently and within a team environment.
• Familiarity with measurement tools (balances, calipers, etc.) preferred.
• Be able to effectively communicate with Production team mates, Supervisor and cross functional team including Quality Assurance, Quality Control, Warehouse and Facilities & Engineering.
• Possess the ability to analyze information and make consistently good decisions
• Ability to follow detailed written procedures and documentation requirements.
• Basic understanding of mechanical equipment and troubleshooting
• Strong attention to detail and commitment to quality.
• Ability to work independently and within a team environment.
• Familiarity with measurement tools (balances, calipers, etc.) preferred.
• Be able to effectively communicate with Production team mates, Supervisor and cross functional team including Quality Assurance, Quality Control, Warehouse and Facilities & Engineering.
• Possess the ability to analyze information and make consistently good decisions
• Perform other duties as assigned

• High school diploma or equivalent / higher required.
• Should have wok experience of equipment operation, product changeovers, cleaning and basic operational troubleshooting for at-least 1 – 2 years in Pharmaceutical / Nutraceutical Production (manufacturing and/or packaging).
• (Experience in Metered dose inhaler (Metered Dose Inhalers (Inhalation) or Derma (Topicals) production would be preferred).
• Familiar with Good documentation and correction practices.
• Should have handful experience of GMP document record execution like batch records, logbooks, protocols, etc.
• Knowledge of deviations/incidents and CAPA.
• A familiarity with cGMPS, CFRs, OSHA and FDA regulations.