PLEASE NOTE: YOU MUST BE AUTHORIZED TO WORK IN THE UNITED STATES TO BE CONSIDERED FOR THIS POSITION. ALSO, YOU MUST HAVE EXPERIENCE IN THE PHARMACEUTICAL / LIFE SCIENCES INDUSTRIES TO BE CONSIDERED.
- 10+ years of Pharmaceutical experience
- 7+ years of CSV (Computer System Validation) experience with laboratory systems including enterprise systems (LIMS, Empower, NuGenesis, ELN)
- 5+ years as a Business Analyst / Sr. Business Analyst
- Ability to work with business owners and system users to define business processes and user requirements
- Ability to assess systems and functional specifications against user requirements
- Experience developing Operation SOPs based on business processes
- Experience with Data Integrity and ALCOA++ principles specific to laboratory systems
- Ability to work onsite in Southeast PA (Lansdale area) with occasional travel to other customer sites
- Perform evaluation of existing HW/SW in the commercialization site laboratories, identify operating system updates required (to get to Windows 10), as well as application impact.
- Communicate with lab personnel and vendors to identify system updates required for compatibility with the new shop floor infrastructure network.
- Support the migration to the new shop floor infrastructure network.