Tech Services Representative

Responsibilities

• Provide onsite processing support to Manufacturing as part of the Technical Transfer Team
• Make and deliver accurate and timely decisions regarding projects and requests
• Escalate issues to departmental managers or directors for corrective action
• Partner with Quality Assurance, Quality Control, and Manufacturing to coordinate projects
• Assist with deviation investigation writing
• Perform filter troubleshooting and testing, including PUPSIT
• Provide expertise in aseptic processing
• Evaluate product impact and advise if product meets regulatory release criteria
• Maintain understanding of Master Batch Records (MBR) and regulatory requirements

Requirements

• BS/BA degree in science or engineering, or 4+ years of pharmaceutical industry experience
• Experience with formulation, filtration, and filling processes
• Knowledge of pharmaceutical, biological, and biochemical quality regulatory requirements
• Familiarity with aseptic formulations, mixing systems, and disposable formulation technology
• Ability to write and perform Technical Services Studies (TSS)
• Proficiency in Microsoft Office Suite and MiniTab
• Experience with enterprise software such as D365, BPLM, Pilgrim, or Trackwise
• Ability to work a weekend shift (Friday to Monday, 4 x 10 hour shifts)

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring sterile injectable products to market.