Duration: 12 months
Validation Engineer job description
The Validation engineer is responsible for the following on Siemens projects:
Development of system life cycle documentation for Siemens Insight Systems for building automation, environmental monitoring, equipment monitoring and system integrations. Documentation includes URS, FS, FDS, FRS, SDS, SDD, HDS, HDD, Control Logic Diagrams, Trace Matrix, SOPs, and other documentation as required by customers.
Development of testing plans including FAT, SAT, Commissioning, and Qualification (IOPQ) to prove system compliance with 21CFR Part 11 for electronic data and electronic signatures.
Author Method of Procedure documents (MOP) and test forms for modifications to qualified systems per customer requirements. Oversee execution and review final executed document and associated test forms to ensure compliance with customer requirements and FDA GDP standards.
Populate test form content specific to system based on approved engineering and/or system specifications.
Interact with customer quality groups, customer engineering, General Contractors, Project managers, Siemens Field Specialists, and Commissioning Agents on multiple projects to facilitate execution of test forms and ensure compliance with FDA good documentation practices and customer SOPs during test execution at all levels.
Review executed testing documentation to ensure compliance with customer requirements and FDA GDP standards.
Manage deviation process during execution of testing. Author deviation form content. Work with the customer to resolve deviations recorded during test execution or system modifications.
Oversee test execution schedule to facilitate efficiency. Support field execution of documentation as needed.
Excellent Interpersonal skills
Efficiency in MS Word, MS Excel, MS Project, Visio, AutoCAD, and Bluebeam.
1 + year experience in a GMP environment.
2 + years Experience with technical writing of life cycle documentation (URS, FS, SDS, HDS, etc)
1+ year Commissioning and Qualification experience
Familiarity with Validation principles and GDP.
Experience/Familiarity with HVAC systems
Experience/Familiarity with Engineering drawings (P&ID, Electrical, Mechanical).
Experience with Siemens Insight system a plus.
Flexibility to adapt to different customer requirements, varying construction issues, and changing schedules/priorities.