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.

Qualifications:

• BS in Engineering or Biological Sciences is required with a minimum of 1-3 years of relevant industry 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)