
Scientist (EMPQ)
- Juncos, PR
- Autónomo
- Tiempo completo
- 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.
- 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