This position reports to nights, 6:00 pm – 6:30 am, 2-2-3, 12.5 hours shift, off every alternate weekend. Due to business need, on select occasions, employees may be required to work overtime.

The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include:

Execution of routine production operationsPerform Batch Record and Form Prep requestsEnter data in the Laboratory Information Management System (LIMS)Record data into log booksSample preparation and testingPropose document revisionsComplete required training on timeCarry out work in a safe manner, notifying management

The individual will manage equipment and support facility related projects by:

Initiating work ordersPerform scheduled cleaning of equipmentPerform standardization of equipmentSupport change over activitiesAssist in the assembly and disassembly of process equipment of safety issues and risksStaff Technical Training and Development:Meet and maintain training requirementsDevelop and maintain personal development planProvide annual performance self assessment on development planLittle to moderate understanding of general job aspects and some understanding of the detailed aspects of the job.

The individual should have the ability to perform functions such as: 

Following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.Possess excellent communication and troubleshooting skills.Familiar with current Good Manufacturing Practices.Basic documentation and computer skills.Will work holidays and overtime as required.May be required to adjust work schedule to meet production demands.Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.Ability to lift, pull or push equipment requiring up to 25-50 lbs of force.Ability to stand for 6 hours in a production suite.Ability to climb ladders and work platforms.Stooping or bending to check or trouble-shoot equipment operations.Ability to work around chemicals (alcohols, acids & bases).Works on assignments that are semi-routine in nature where ability to recognize deviations from accepted practice is required.Receives assignments in the form of objectives with goals and process to meet goals outlined. Work is reviewed by supervisor to measure meeting of objectives.Accomplishes tasks mainly through direct operation of cGMP activities.Performs daily operations of the work unit and actively assists coworkers in fulfilling department goals elevating issues to senior staff.