Validation Engineer

Responsible for designing, executing, and document equipment and processes validations following procedures of and quality regulations of the client. 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

• Develop and execute IQ, OQ, and PQ protocols for product, processes, facilities, software and equipment within the client’s facility.
  


• Review existing validation reports and identifies gaps for GMP compliance.  Develop strategies and plans to close the gaps in an efficient and technical manner.
  


• Monitor and drive corrective action and continuous improvement activities that directly impact performance measures. 
  


• Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports. 
  


• Provide guidance and understanding on all equipment qualification methodologies as required by Pharmaceutical/Medical Device industry within client’s site.
  


• Participates on project teams to create and/or approve (as applicable) the following: equipment & software risk management documentation, equipment design reviews, equipment verification and validation documentation.
  


• Support manufacturing/quality/engineering teams in the area of Process Validation to ensure that equipment related risks are identified and mitigated accordingly through testing.
  


• Assist in risk assessment activities (i.e. process map, value stream map, fish bone diagram, etc.) for equipment improvements or new equipment/process development.
  


• Support activities of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with client’s specifications.
  

Requirements

BS Degree in Engineering or Applied Sciences.  One (1) to five (5) years of work experience in a similar role. Strong customer service skills are necessary.

-       Proven experience working with problem solving skills and familiarity with DMAIC problem solving tools.