Job Description

*This position requires employees to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation.*

Job Summary:

The Manufacturing Operator executes routine unit operations within the Assembly and Packaging areas of a multi-product pharmaceutical manufacturing facility. This role supports the assembly and packaging of drug products, assists with equipment setup and troubleshooting, and ensures adherence to SOPs and GMP standards for manufacturing operations.

Responsibilities:

• Assist in setting up automated and semi-automated machines (e.g., autoinjector, pre-filled syringe assembly machines).
• Support minor equipment repairs, adjustments, and changeovers.
• Identify and address operational issues, including mechanical or component problems, in real-time.
• Document all work in accordance with SOPs, including batch records and logbooks.
• Perform cleaning and sanitization of production areas, including waste disposal and room preparation.
• Verify equipment calibration and ensure controlled document compliance.
• Assist with assembly, packaging, and visual inspection/filling operations.
• Maintain inventory of components and materials to ensure readiness for production.
• Ensure adherence to safety standards and escalate unsafe conditions or behaviors.
• Maintain production areas following 5S standards.
• Communicate effectively with shift personnel during hand-offs and changes.

Qualifications:

• High school diploma required; Associate's/Bachelor's degree or biotechnology vocational training preferred.
• Minimum of 1 year of experience in a GMP-regulated environment, preferably within the biotechnology or pharmaceutical industry.
• Must adhere to SOPs, proper documentation practices, and cGMP regulations.
• Physical ability to stand and walk for extended periods, and lift up to 40 lbs as required.

Job Tags

Similar Jobs