12 days old

Senior Manufacturing Associate

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421
  • Job Code
    R0027190

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Job Description

This position reports to Nights, 6:00 pm 6:30 am, 2-2-3, 12.5 hours shift, off every alternate weekend. Due to business need, on select occasions, employees may be required to work overtime.

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

The Senior Manufacturing Associate will carry out cGMP manufacturing cleaning and disinfection operations utilizing Standard Operating Procedures (SOPs).

Responsibilities:

  • Troubleshoot and escalate process related issues

  • Create work orders as needed

  • Initiate and document minor deviations

  • Inform management of events impacting schedule

  • Request and execution of GMP documentation

  • Enter data in the Laboratory Information Management System (LIMS), MODA and other business systems

  • 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

  • Participate in tiered visual management system and support continuous improvement initiatives

  • Initiating work orders

  • Act as subject matter expert for improvement projects

  • Perform scheduled cleaning of equipment

  • Assemble and disassemble process equipment

  • Perform standardization of equipment

  • Support change over activities

  • Execution of equipment and process qualifications and validation

  • Provide technical training for area personnel

  • Provide input on training material development

Requirements

Minimum:

  • High School Diploma or an Associate degree in Life Sciences/Engineering field

  • 4+ years related industry experience

Preferred:

  • Biotech Certificate

Other Job Requirements

Prior experience in the following activities preferred:

  • Standardization and measurements utilizing bench top equipment (i.e. Osmometer, conductivity meter, etc.)

  • Execution of cleaning and disinfection operations

    • Bleaching of materials prior to entry into cleanrooms

    • Record data into logbooks and log sheets

    • Preparation of cleaning and disinfection solutions

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

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-01-06 Expires: 2021-02-04
Sponsored by:
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Sponsored by:
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Senior Manufacturing Associate

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421

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