Lead Manufacturing Technician- 2nd shift- Sunday to Wednesday
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POST DATE 9/15/2016
END DATE 12/17/2016
JOB DESCRIPTIONJob Description
PRIMARY ROLE: 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 write and edit SOPs, and maintenance of production equipment. Maintains records and clean room environment to comply with regulatory requirements, GMPs, and SOPs. Review and execute validation protocols. Will formulate and recommend improvements to manufacturing policies and programs. Provide in-process testing to assure batches meet specifications. Will train personnel in new and revised procedures. Leads daily on-floor operations.
100%: Uses ability as a skilled specialist to contribute in development of concepts and techniques, and to complete tasks in creative and effective ways. Will mentor less skilled support staff.
Incumbent will be required to make process decisions, 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 offer recommendations for process and system improvements.
Will be required to identify process deviations and take immediate action to mitigate event.
EDUCATION & EXPERIENCE REQUIREMENTS: Normally requires a high school diploma and a minimum of 6+ years related industry experience or a life sciences / engineering related bachelors degree and 4+ years of related experience.
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's BRAVE culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
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.