Manufacturing Associate Ii
vor 1 Monat
**Job Description** About This Role**
As a Manufacturing Associate II, you will perform and document daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents. Your responsibilities also involved ensuring compliance to cGMP as well as maintaining equipment and facilities. The Manufacturing Associate II is detail-oriented and possess strong documentation skills. In addition to that, it is expected to maintain training level to the required level and support other functions on site.
**What You’ll Do**
- Execute manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentation
- Perform troubleshooting/investigation of equipment and process issues
- Revise documents as instructed, Capable of equipment and/or process changes
- Actively participate in training activities, managing their individual training plan and train other associates as required.
- Execute validation protocols
- Capable of leading shift when supervisor is absent, and actively leads or participates in shift exchanges.
- Coordinate activities and daily schedules with cross-functional areas.
**Qualifications** Who You Are**
You are able to demonstrate the ability to independently document and record information related to their job functions. You have basic understanding of the Biotech process and are able to follow and comply with written procedures and protocols and possess a solid understanding of the requirements within correct and timely documentation within a cGMP environment.
**Required Skills**:
- 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
- Exposure to Delta V or Syncade or similar automated systems
- Experience in highly regulated industry
- Good verbal and written skills are required to ensure proper description of any issues.
**Additional Information**
**Why Biogen?**
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
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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