Job ID: 24-02935
Qualifications:
Education:
BS in Engineering or Biological Sciences is required with a minimum of 1-3 years of relevant industry experience.
Required Skills and Experience:
• Experience with working in a GMP environment
• Knowledge of GMP documentation requirements • Ability to work independently and in a team environment.
Desired Skills and Experience:
• Previous experience in manufacture of large molecule (vaccines or biologics) • Knowledge of SAP system is a plus
• Familiarity with electronic document management systems, such as Veeva Vault.
Strong technical writing skills (in a GMP environment is an asset)
Strong organizational and communication skills
• Managing timelines and schedules, especially when working on multiple projects • Proficient in MS Word, working knowledge of MS Office (Excel, PowerPoint)

Responsibilities:
Candidate will participate in a range of activities including, but are not limited to:
• Authoring and revising SOPs compliant with Good Documentation Practices (GDP) to support upcoming business system implementation in large molecule manufacturing area • Working with several business area SMEs, integrate functional and technical requirements from manufacturing and other support groups into SOPs to ensure compliance with the new business system implementation.