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
• 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 & 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
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.