Shire Sr Manufacturing Technician (1st shift, Sun-Wed) in Lexington, Massachusetts
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. Will formulate and recommend improvements to manufacturing policies and programs. May assist with in-process testing to assure batches meet specifications. May assist in training personnel.
Uses ability as a skilled specialist in accordance with company policies and procedures to complete complex tasks in creative and effective ways. May mentor less skill 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.
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
This individual will manage equipment and support facility related projects by
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
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 a minimum of 4-6 years related industry experience or a life sciences / engineering related associate’s degree / biotech certificate and 2-4 years of related experience.
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.
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Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.
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.