Scientist (EMPQ)

• Develop and execute Environmental Qualification, Airflow Visualization Study (AVS) and Aseptic Process Simulation (APS) deliverables for operational readiness projects
• Responsible for the Activities before Environmental monitoring performance qualification (EMPQ) execution
• Responsible for the EMPQ execution & post approval
• Responsible for the Air Visualization Studies
• Responsible for the Aseptic Process Simulation Media Fill (MF)
• Participate in project meetings, as applicable
• Generate Validation Plan establishing lean strategies, as required
• Develop and execute EM PQ, AVS and APS protocols for applicable systems
• Develop EM PQ, AVS and APS reports for applicable systems
• Evaluate, coordinate, and execute the required efforts (resources, plant support, equipment, materials, etc.) to support projects deliverables
• Comply with projects schedule and escalate any roadblock or issues immediately including proposed mitigation plan
• Provide support during documentation transfer to DMS or Quality

• Bachelor’s degree in Engineering or a Scientific field
• 5+ years of experience in a regulated industry
• Experience with Environmental monitoring performance qualification (EMPQ) execution
• Preferred experience with Aseptic Process Simulation Media Fill (MF)
• Strong knowledge of cGMP/FDA regulations
• Strong communication skills (oral and written)
• Ability to organize and manage multiple tasks in a fast-paced environment
• Attention to detail
• Demonstrated problem solving and analytical skills

Preferred experience with Aseptic Process Simulation Media Fill (MF)

• Medical, dental, and vision care
• Comprehensive suite of benefits focusing on physical, emotional, financial, and social aspects of wellness
• Support for working families (backup dependent care, adoption assistance, infertility coverage, family building support)
• Behavioral health solutions
• Paid parental leave
• Paid caregiver leave
• Training programs
• Professional development resources
• Opportunities to participate in mentorship programs, employee resource groups, volunteer activities