Posted in General Business 30+ days ago.
Type: Full-Time
Location: Cambridge, Massachusetts
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice, Privacy Policy and Terms of Use.
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
Full time
Thermo Fisher Scientific
|
Thermo Fisher Scientific
|
Thermo Fisher Scientific
|
Alvarez & Marsal Private Equity Performance Improvement Group, LLC
|
Alvarez & Marsal Private Equity Performance Improvement Group, LLC
|
Alvarez & Marsal Private Equity Performance Improvement Group, LLC
|