Validation Engineer II - Building Automation Solutions - Hayward CA
Business Unit: Field Operations
Requisition Number: 222756
Primary Location: United States-California-Hayward
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%
Develops system life-cycle documentation for Siemens computer-based controls 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.
Develops testing plans including FAT, SAT, Commissioning, and Qualification (IOPQ) to prove system compliance with 21CFR Part 11 for electronic data and electronic signatures.
Authors Method of Procedure (MOP) documents and test forms for modifications to qualified systems per customer requirements. Oversees execution and reviews final executed document and associated test forms to ensure compliance with customer requirements and Food and Drug Administration Good Documentation Practices standards.
Populates test-form content specific to system based on approved engineering and/or system specifications.
Interacts with customer quality groups, customer engineering teams, 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.
Reviews testing documentation to ensure compliance with customer requirements and FDA GDP standards.
Manages deviation process during execution of testing. Authors deviation form content. Works with the customer to resolve deviations recorded during test execution or system modifications.
Oversees test execution schedule to facilitate efficiency. Supports field execution of documentation as needed.
- Required education: High School Diploma, state-recognized GED, or state-recognized high school proficiency exam.
- Required experience: At least two years of experience as a validation/quality engineer or Building Automation Engineer.
- Required travel: 5%
- Other requirements:
- Must be proficient in the use of Microsoft Office.
- Must have excellent communications skills (written and verbal) in English, using tact and diplomacy when dealing with customers.
- Preferred education: Bachelor of Science degree
- Other preferences:
- Good understanding of mechanical HVAC systems
- Proficiency with AutoCAD, and Bluebeam.
- Familiarity with Validation principles and GDP.
- Two years of experience with technical writing of life-cycle documentation (URS, FS, SDS, HDS, etc)
- Experience/Familiarity with engineering drawings (P&ID, Electrical, Mechanical).
- Siemens is a globally diversified engineering powerhouse: an opportunity such as this one can open doors to engineering practices and businesses new to you, preparing you for a great future with potential in so many types of fields—sustainability, energy, medical technologies, to name a few—in almost any location you ever dreamed of exploring.
- Competitive compensation.
- Excellent health, dental, and vision plans with many options from which to choose.
- All employees receive Life Insurance, Short and Long Term Disability coverage.
- 401k match dollar for dollar up to 6% of gross salary.
- Education and tuition reimbursement programs available.
- Extensive product training and professional career development.