Pharmaceutical Packaging Operator

Responsible for operating and managing high-speed pharmaceutical packaging lines in compliance with SOPs, cGMPs, and safety standards. Ensures product quality, accurate documentation, and efficient line performance while supporting team goals and continuous improvement.

• Operate and monitor manual/automated equipment for assembly, filling, labeling, and packaging.
• Perform line set-ups, changeovers, and clearances per SOPs and GMPs.
• Conduct in-process inspections, verify components, and reconcile product counts.
• Maintain cleanrooms and equipment following cGMP and 5S standards.
• Accurately complete batch records, logbooks, and documentation.
• Accept/reject products based on quality standards.
• Collaborate with maintenance and team members to resolve issues and improve processes.
• Participate in training, meetings, and team development activities.

Regulatory Compliance:

• Adhere to FDA, ISO 13485, EC MDD, CMDR, OSHA, EPA, and other global regulatory standards.
• Support environmental, health, and safety initiatives.

Requirements:

• High School diploma or equivalent.
• 1+ year experience in high-speed manufacturing (pharma preferred).
• Familiarity with GMP environments and aseptic production.
• Basic Microsoft Office and SAP knowledge.

Skills & Physical Requirements:

• Strong attention to detail, math skills, and manual dexterity.
• Effective communication and teamwork.
• Ability to lift (up to 40 lbs for men, 35 lbs for women), stand, bend, and stretch.
• Willingness to work any shift (up to 12 hours) and comply with gowning protocols.

Time Allocation:

• 50%: Equipment operation and packaging.
• 30%: Documentation and compliance.
• 20%: Team collaboration and process improvement.