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The consultant will develop and execute Environmental Qualification, Airflow Visualization Study (AVS) and Aseptic Process Simulation (APS) deliverables for operational readiness projects. This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.
Job Responsibility:
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
Requirements:
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
Nice to have:
Preferred experience with Aseptic Process Simulation Media Fill (MF)
What we offer:
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