Formulation Process Operator

Location: Newark, DE
Date Posted: 01-10-2018

This position is responsible for operating a variety of Formulation equipment/processes to ensure production requirements are met, while following company policies/procedures and maintaining compliance with FDA and other Global Regulatory requirements. 

Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.) 

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title: 

• Must demonstrate ability to properly operate equipment, perform equipment set-up/change-over/cleanups, assist in preventative maintenance and troubleshoot equipment problems 
• Performs responsibilities ensuring compliance with Newark Site standards, policies, and SOP’s, as well as performing job responsibilities in compliance with Safety, Health & Environment standards. To include: following and properly completing all activities while in compliance with GMP policies, safety requirements, and ensuring required documentation 
• Works with Process Facilitators and other Operators/Mechanics/Technicians to identify and implement opportunities for improvements in equipment/production efficiencies. Supports new equipment start-up and quickly learns new systems, equipment and procedures. Supports the development/validation of new products/procedures. 
• Must be flexible in responding to changes to equipment/production assignments. 
• Must be able to demonstrate good interpersonal skills and work in a team environment, with other operators, mechanics, technicians, supervision and project management with the goal of completing planned production and furthering Newark Site and initiatives. 
• Must be able to work other shifts, weekends, alternative schedules when production demands require. 

Education, Qualifications, Skills and Experience 

Essential Desirable 
• High School Diploma. 
• One year experience in a production environment 
• Demonstrated problem solving and troubleshooting skills 
• Basic mechanical aptitude 
• Basic computer skills 
• Good interpersonal, communication and writing skills. 
• Ability to perform duties with minimal supervision. 
• Knowledge of cGMP’s. • Three years experience as an operator in a production environment, pharmaceutical experience a plus 

• Site personnel including department management, supervision and colleagues. 
• Work with vendors and contractors providing services and installing new equipment. 

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