Shire Manufacturing Tech II (1st shift, Wed-Sat) in Lexington, Massachusetts
With general supervision the individual will perform routine and critical 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.
This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include the following
• Troubleshoot and resolve process related issues
• Initiate and document minor deviations
• Execution of critical and routine production operations
• Perform Batch Record, Log Book and Form Prep requests
• Enter data in the Laboratory Information Management System (LIMS)
• Record data into log books
• Review log book data
• 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
This individual will manage equipment and support facility related projects by
• Initiating work orders
• Assembly and disassembly of process equipment
• Perform scheduled cleaning of equipment
• Perform standardization of equipment
• Support change over activities
• Execution of equipment and process qualifications as well as validation
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 2-4 years related industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience. Biotech Certificate preferred
Prior experience in the following activities preferred:
• Process automation
• Standardization and measurements utilizing bench top equipment. (i.e. pH meter, osmometer, conductivity meter, etc.)
• Basic Ultra filtration knowledge
• Basic Cell culture knowledge
• Process automation
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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, 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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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.