Shire Manufacturing Technician (1st Shift - Sun-Weds) in Lexington, Massachusetts

Primary Duties:

With direct supervision this individual will perform routine manufacturing operations for the production of clinical and/or commercial products. Operates production equipment according to SOPs in their assigned areas

Responsibilities:

80%

The individual will carry out cGMP manufacturing operations

utilizing Standard Operating Procedures (SOP), Batch Records

and Form Preps. Primary responsibilities include

  • Execution of routine production operations

  • Perform Batch Record and Form Prep requests

  • Enter data in the Laboratory Information Management

  • System (LIMS)

  • Record data into log books

  • 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%

The individual will manage equipment and support facility

related projects by

  • Initiating work orders

  • Perform scheduled cleaning of equipment

  • Perform standardization of equipment

  • Support change over activities

  • Assist in the assembly and disassembly of process

  • equipment

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 0-2 years related industry experience or an Associates Degree in Life Sciences/Engineering field. Biotech Certificate preferred

Key Skills, Abilities, and Competencies:

Little to moderate understanding of general job aspects and some understanding of the

detailed aspects of the job.

  • The individual should have the ability to perform functions such as: Following

  • written instruction in the form of Batch Records, Form Preps, Technical Protocols

  • and Procedures.

  • Possess excellent communication and troubleshooting skills.

  • Familiar with current Good Manufacturing Practices.

  • Basic documentation and computer skills.

  • Will work holidays and overtime as required.

  • May be required to adjust work schedule to meet production demands.

  • 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 semi-routine in nature where ability to recognize deviations from accepted practice is required.

  • 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.

Internal and External Contacts:

Internal:

All Internal Manufacturing, Materials Management, Technical Operations and Facilities Management with limited exposure to support groups (Validation, Quality Control Process Development)

Vendor:

May require interaction with equipment, technical and supply item vendors.

Other Job Requirements:

  • May be required to travel to Shire Manufacturing site in Cambridge, MA on occasion.

  • Will be required to enter data into SAP as necessary

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, 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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

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

Reasonable Accommodations

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.