With direct supervision this individual will perform routine manufacturing operations for the
production of clinical and/or commercial products. Operates production equipment according to
SOPs in their assigned areas.
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 operations
• Perform Batch Record and Form Prep requests
• Enter data in the Laboratory Information Management System (LIMS)
• Record data into log books
• Sample preparation and testing
• Propose document revisions
• Complete required training on time
• Carry out work in a safe manner, notifying management of safety issues and risks.
The individual will manage equipment and support facility related projects by:
Initiating work orders
• Perform scheduled cleaning of equipment
• Perform standardization of equipment
• Support change over activities
• Assist in the assembly and disassembly of process equipment.
Staff Technical Training and Development
• Meet and maintain training requirements
• Develop and maintain personal development plan
• Provide annual performance self assessment on development plan
Education and Experience Requirements
Normally requires a high school diploma and 0-2 years related industry experience or an
Associates Degree in Life Sciences/Engineering field. Biotech Certificate preferred.
Key Skills, Abilities, and Competencies
Little 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).
Complexity and Problem Solving
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.
Internal and External Contacts
• All Internal Manufacturing, Materials Management, Technical Operations and Facilities
Management with limited exposure to support groups (Validation, Quality Control, Process
Development and Health, Safety & Environment.)
• May require interaction with equipment, technical and supply item vendors.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.