Lead Monistat Production Tech - 1st Shift

TITLE: Lead Monistat Production Tech – 1st Shift

DEPARTMENT: Monistat

OCCUPATIONAL SUMMARY:
This Lead Monistat Production position is responsible for ensuring the quality and timely delivery of full-scale validation & commercial batches to the Supply Chain team from the Secondary Packaging and Cream Production Suites. This role will serve as the lead technology expert for primary packaging equipment and serves as a leader for the Production Technicians team. The Leader is to demonstrate expertise during the training, setup, operation and changeover of Production equipment, as well as primary packaging equipment. Strong mechanical aptitude is required.

This position will be instrumental in transferring cGMP standards to new staff as they are onboarded. The Lead Technician will lead and participate in small Maintenance and Operations Team meetings which will make decisions that ensure the production schedule is met in a safe and quality conscious manner.

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.
• Drives decisions and owns responsibility to meeting schedule commitments

RESPONSIBILITIES:
• Assist in the planning and scheduling of commercial batches
• Lead and assist in the successful manufacturing of commercial and full-scale validation batches
• Maintain the inventory system for raw materials and primary packaging components
• Troubleshoot, diagnose, and repair machine breakdowns if maintenance support is not required
• Assist in decisions on equipment selection, purchases, and processes
• Lead team in the set-up and change-over of production and primary packaging equipment
• Ensure manufacturing area and equipment are maintained in accordance with company and regulatory requirements
• Recognize potential problems and provide input on corrective action
• Lead & assist in training staff for Cream Production and Primary Packaging
• Identify and resolve process and/or equipment failures; initiate appropriate action to prevent recurrence
• Maintain machines to ensure that SOP’s and Work Instructions are adhered to, and quality product is provided according to all cGMP documentation.
• Responsible to maintain work area in a safe, clean and orderly condition according to cGMP documentation.
• Lead in the execution of validation protocols as they pertain to batching and/or equipment qualifications
• Assume operational control of the department to the extent required in the absence of departmental management.
• Provide technical guidance and training to personnel as required.
• Writes and updates SOP’s and Work Instructions for the areas assigned.
• Perform other related duties as required

PHYSICAL REQUIREMENTS:
• 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 community 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
• Must be able to work in a team environment
• Must be able to use a variety of tools, equipment, and machinery

QUALIFICATIONS:
• High school diploma or equivalent with at least six years of equivalent pharmaceutical industry experience
• Associate’s degree with at least four years of equivalent pharmaceutical industry experience
• Bachelor’s degree (scientific degree preferred) with at least two years of relevant experience
• Experience in an FDA regulated industryand a thorough functional understanding of pharmaceutical manufacturing processes and cGMPs

ACCOUNTABILITY:
Manager, Project Production

WHAT WE OFFER
Here at Fleet, you can have a good job that can grow into a great career.

• The start of a great career working with a diverse group of great people
• The health and safety of every employee... our top priority
• A clean, air-conditioned cGMP environment
• Top notch benefits –paid time off, 401(K) retirement savings with company match, medical, dental and vision, pay annual targeted bonus, competitive pay, life insurance, Flexible spending account, and tuition reimbursement.
• Stability – a record of strong financial performance and part of a growing $1billion company
• A business supporting the Lynchburg community for over 150 years.

No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.