Manufacturing Associate V
Vor 5 Tagen
**Company Description** About This Role**
As a Manufacturing associate V you'll perform and document daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, and revising cGMP documentation. Ensures compliance to cGMP as well as maintaining equipment and facilities. The manufacturing associate is detail-oriented with strong understanding of automated systems and process controls. Individual will maintain training to the required level and support other functions on site.
**What You’ll Do**
- 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
**Job Description** Who You Are**
You are someone developing a deep passion for doing work that furthers a mission to save lives. You have a high degree of demonstrated learning agility, are energetic, and love a fast-paced work environment where everything you do is incredibly impactful. With many years of related industry experience and exposure to automated systems like Delta V or Syncade, you bring a wealth of knowledge to ensure the highest compliance standards are met.
**Required Skills**:
- Bachelor degree in not related field and typically 10+ years Pharma/Biotech years experience
- Strong understanding of Delta V or Syncade or similar automated systems (potentially able to solve level 1 automation issues)
- Experience in highly regulated industry
- Understanding of full Biotech process
- Languages: English B2 level, German and/or French an asset
**Additional Information**
**Why Biogen?**
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts
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