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Manufacturing Technician I/II 2nd shift Sun - Wed
Performs routine manufacturing operations for the production of clinical and/or commercial products. Operates production equipment according to SOPs. Performs manufacturing activities of full scope, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Will be required to assist with writing and editing SOPs, and maintenance of production equipment. Maintains records and clean room environment to comply with regulatory requirements, GMPs, and SOPs. May assist with the execution of validation protocols. May assist with in-process testing to assure batches meet specifications.
Applies job skills and company policies and procedures to complete a wide range of difficult tasks. May mentor less skilled staff.
Incumbent will be required to make process decisions, with the help of supervision, including the trouble shooting of equipment, corrective action to process deviations.
Individual will be required to understand operations and contact appropriate support to ensure issues are appropriately resolved.
Will be required to identify process deviations and with guidance take immediate action to mitigate event.
General supervision and instructions given for routine work and detailed instructions given for new activities or special assignments.
EDUCATION & EXPERIENCE REQUIREMENTS:
Normally requires a high school diploma and a minimum of 2-4 years related industry experience or a life sciences / engineering related associates degree / biotech certificate and 0-2 years of related experience.
KEY SKILLS, ABILITIES, AND COMPETENCIES:
Substantial understanding of general aspects of the job with a broad understanding of the detailed aspects of the job.
The individual should have the ability to perform functions such as: Technical Writing of Reports and Procedures, Excellent Communication, Strong Troubleshooting Skills and current Good Manufacturing Practices.
Documentation and computer skills.
Basic statistical mathematical and project management skills.
DNA Capabilities: Delivering Excellence, Embracing Change, Accountability and Ownership
May be required to perform as a subject matter expert for equipment and/or systems.
OTHER JOB REQUIREMENTS:
Will be required to lift 70 lbs (31 kg)
Will work holidays and overtime as required.
May be required to adjust work schedule to meet production demands.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
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.
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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.