Manufacturing Associate II (DSP & USP)
The resources will need to work in either 2 shift extended or 5 shift model. Please just submit candidates who are ok to work in shift. Please note we need candidates either with DSP and USP experience.
Summary:
- Performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents. Ensuring compliance to cGMP as well as maintaining equipment and facilities. The MA is detail-oriented with strong documentation skills. Maintain training level to the required level and support other functions on site.
Minimum Education Requirements
- Minimum educational level necessary to perform the job (High School diploma, Associate's Degree, Bachelor's Degree, Masters, PhD)
Principal Accountabilities
- 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 shift 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.
Must Haves
* High school diploma or equivalent experience and typically 3-5 years relevant experience in related or non-related industry or 2-3 years experience in Pharma/Biotech industry
OR
Bachelor degree in related filed with 1-2 years professional experience
OR
- Bachelor degree in not related field and typically 3-4 years experience
- Languages: English B1, German and/or French an asset
- The employee must have basic understanding of the Biotech process.
- The employee must be able to follow and comply with written 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 at least one manufacturing department. Employee must have basic Automation understanding or must be at ease with technology platforms.
If you believe you are a good fit, please do not hesitate to contact me directly on: +41 61 282 22 13 (Alba Jansa)
À propos de l'entreprise
