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Shire Manufacturing Technician II in Lexington, Massachusetts
Primary Duties :
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.
80% 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
10% 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
10% 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 and Experience Requirements:
Normally requires a high school diploma and 2-4 years related industry experience or an Associates Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience. Biotech Certificate preferred
Key Skills, Abilities, and Competencies:
Significant understanding of general aspects of the job with a broad understanding of the detailed aspects of the job.
May 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.
Will work holidays and overtime as required.
May be required to adjust work schedule to meet production demands.
Proficient in Aseptic Technique
Ability to work cohesively in a team environment
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).
Complexity and Problem Solving:
Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
Basic trouble shooting skills
Receives assignments in the form of objectives with goals and process to meet goals outlined. Work is reviewed by supervisor to measure meeting of objectives.
Accomplishes tasks mainly through direct operation of cGMP activities.
Performs daily operations of the work unit and actively assists coworkers in fulfilling department goals elevating issues to senior staff.
Evaluate and elevates issues to senior staff.
Identifies process deviations, troubleshoots issues and identifies process improvements.
Internal and External Contacts:
- All Internal Manufacturing, Materials Management. Technical Operations and Facilities Management with limited exposure to support groups (Quality Assurance, Validation, Quality Control Process Development)
- May require interaction with equipment, technical and supply item vendors.
Other Job Requirements:
Prior experience in the following activities preferred:
Standardization and measurements utilizing bench top equipment. (i.e. pH meter, osmometer, conductivity meter, etc.)
Basic Ultra filtration knowledge
Basic Cell culture knowledge
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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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
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.