For our client, an international biotech company, we are looking for a :
Manufacturing associate IV
Contract : permanent
Main Responsibilities :
Your mission is to perform and document daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation.
You will ensure compliance to cGMP as well as maintaining equipment and facilities.
The manufacturing associate is detail-oriented with a strong understanding of automated systems and process controls.
Executes manufacturing processing steps and / or manufacturing support activities, monitoring the process against the recipe & MFG documentation
Perform troubleshooting / investigation of equipment and process issues
Revises documents as instructed, Capable of equipment and / or process changes
Actively participates in training activities, managing their individual training plan. Trains other associates as required.
Executes validation protocols
Capable of leading shifts when supervisor is absent, and actively leads or participates in shift exchanges. Coordinates activities and daily schedules with cross-functional areas.
And other job duties that may be assigned from time to time.
Your profile :
Relevant education from chemical industry, food industry, pharmaceutical or biotech industry.
Industry or process operator or technical craftsman with at least 5-8 years of experience from a similar position.
Able to work in shifts.
Should be able to assess and troubleshoot equipment and process issues
Be able to work independently and with minimal direction.
Knowledge of biopharmaceutical technology and processes.
The employee must be able to follow and comply with procedures and protocols.
The employee should occasionally be able to make routine decisions based on gained experience.
The employee must have a solid understanding of the requirements within correct and timely documentation within a cGMP environment.
The employee must be trained and skilled in all operational and regulatory procedures of manufacturing department.
Capable of supporting the authoring of technical reports and summaries to support investigations.