Experience

PACIV

• United States
• Industrial Automation
• 1 - 100 Employee

• Sr. Automation/Validation Engineer

  • Dec 2016 - Present



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Automation Engineer

  • Jan 2010 - Apr 2016

  •Manage service contractors tasked with maintaining site utility systems. •Execute work orders and perform troubleshooting on utility computer systems, including building automation systems, standalone equipment, and critical laboratory equipment, ensuring proper operation of HVAC, water, and wastewater treatment systems. •Generate and close most of department’s Class 1 Non-conformances (non-critical deviations from processes) within five calendar days, as mandated.•Create and close Corrective Action Preventive Action (CAPA)•Own, assess, and manage Change Controls (records of modifications to critical equipment). Ensure all modification activities are completed as scheduled. •Oversee, revise, and approve utility systems user and system administration standard operating procedures•Generate and execute validation documents e.g. function test and IOQs.•Responsible for assessing and ensuring that systems owned are 21 CFR Part 11 compliant.

• Manufacturing Associate

  • Sep 2004 - Jan 2010

  •Performed viral inactivation and neutralization, chromatography operations, UF/DF operations, and viral filtration.•Supported manufacturing operations by performing CIPs, SIPs, bench top laboratory operations (pH, conductivity, and UV analysis), column packing and unpacking operations, and membrane change out.•Trained associates in operational procedures and supporting activities, such as membrane change out, chromatography column packing and unpacking, CIPs, SIPs, and use of bench equipment.•Troubleshot issues and generated work orders to ensure problems were resolved. Identified pressure leaks that caused pressure hold tests to fail and determined reason steam target temperatures were not being reached during SIP operations. •Executed validation protocols and engineering test plan.•Generated Non-conformances (NC) when they occurred and assisted in prompt closure of Class 1 NCs.•Ensured adherence to manufacturing process scheduling. Managed human resources to guarantee completion of required operational tasks on daily basis. •Reviewed batch records to ensure proper documentation practices were followed.•Participated on team tasked with decommissioning one of the manufacturing buildings on site.