Monistat Manufacturing Technician II

Accountabilities

• Ensure equipment readiness, minimize downtime, and suggest equipment improvements to drive OEE improvements and support efficient production demands.
• Perform periodic reviews with maintenance staff of the OEE tracking system to ensure full functionality and cGMP compliance.
• Owns responsibility to meet schedule commitments.
• Understands, performs, and maintains work activities in accordance with Current Good Manufacturing Practices (cGMP) (21 CFR 210 & 211) in all areas of business where the cGMPs apply.
• Responsible for cleaning and inspection of equipment to the level required for maintenance and issuing Work Orders for associated tasks.
• Responsible for daily/weekly/monthly machine lubrication that is not detailed in the Preventative Maintenance plan.
• Responsible for troubleshooting and repairing small equipment adjustment requirements and minor issues due to normal production activities.
• Aid in the successful manufacturing of commercial and full-scale validation batches.
• Aid in maintaining the inventory system for raw materials and primary packaging components.
• Set-up and change-over of production and primary packaging equipment.
• Performs line clearance of assigned production lines as required.
• Ensure manufacturing area and equipment are maintained in accordance with company and regulatory requirements.
• Recognize potential problems and provide input on corrective action.
• Aid in training staff for Cream Production and Primary Packaging.
• Identify and resolve process and/or equipment failures; initiate appropriate action to prevent reoccurrence.
• Maintain machines to ensure that SOP’s and Work Instructions are adhered to and quality product is provided according to all cGMP documentation.
• Perform other related duties as required & lead by example.

Physical Demands

• Position requires the ability to lift in excess of 50 lbs unassisted.
• Majority of workday is performed while standing, walking, lifting, pulling, pushing.
• Requires the ability to communicate effectively using speech, vision, and hearing.
• Requires the use of hands for simple grasping and fine manipulations.
• Requires bending, squatting, reaching, pushing, climbing.
• Requires the ability to stand for extended periods of time.
• Some exposure to hazardous chemical and other active chemical ingredients.

Qualifications

• High school diploma or equivalent with at least two years of equivalent pharmaceutical industry experience or four years cGMP related experience.
• Experience in an FDA regulated industry and a thorough functional understanding of pharmaceutical manufacturing processes and cGMPs.