Lynchburg, VA
Full Time
Mid Level
OCCUPATIONAL SUMMARY:
The Technician II, Cream Production position is responsible for ensuring the quality and timely delivery of full-scale validation & commercial batches to the Supply Chain team from the Cream Production Suite. In addition, this role will serve as a cross-trained asset for primary packaging equipment. The individual is to demonstrate expertise during the training, setup, operation, changeover and basic maintenance of Production equipment, as well as primary packaging equipment.
This person will 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.
This position will be instrumental in transferring cGMP standards to new staff as they are onboarded.
Pay Range: $21.36 – $27.27
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 meeting 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.
Responsibilities
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
Assist in the successful manufacturing of commercial and full-scale validation batches
Assist 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
Assist 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 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 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
