With limited supervision this individual will perform routine and non routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. Will support engineering and validation activities.
70%: This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form
Preps. Responsibilities include
• Troubleshoot and resolve process related issues
• Create work orders as needed
• Initiate and document minor deviations
• Execution of critical and routine and non routine production operations
• Informing management of events impacting schedule
• Perform Batch Record, Log Book and Form Prep requests
• Enter data in the Laboratory Information Management System (LIMS)
• Record data into log books
Review manufacturing documentation real time to ensure compliance
• Coordinate sample preparation and testing
• Propose and review document revisions
• Carry out work in a safe manner, notifying management of safety issues and risks
15%: This individual will manage equipment and support facility related
• Initiating work orders
• Act as subject matter expert for improvement projects
• Perform scheduled cleaning of equipment
• Assembly and disassembly of process equipment
• Perform standardization of equipment
• Support change over activities
• Execution of equipment and process qualifications and validation
15%: Working with supervision this individual will
• Provide technical training for area personnel
• Provide input on training material development
• Meet and maintain training requirements
• Develop and maintain personal development plan
• Provide annual performance self assessment
Education & Experience Requirements:
Normally requires a high school diploma and 4-6 years related industry experience or an
Associates Degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing
experience. Biotech Certificate preferred
Key Skills, Abilities, & Competencies:
Will be required to perform as a subject matter expert for equipment and/or systems
• The individual is proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
• Possess excellent communication and troubleshooting skills.
• Full awareness of current Good Manufacturing Practices.
• Proficient computer skills.
• Proficient in Aseptic Technique
• Ability to work cohesively in a team environment
• Experience with business systems such as ERP, LIMs, and Trackwise
• Will work holidays and overtime as required.
• May be required to adjust work schedule to meet production demands.
• Proficient in Aseptic Technique
• 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).
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.