Validation Engineer for Life Sciences
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About this role:
The Validation Engineer is responsible for the execution and management of validation projects within North American.
*Candidate can live anywhere in the US as long as they are near a major airport.
- Development of support systems to improve operational effectiveness of branch operations on cGMP/cGLP regulated projects
- Assist field offices on issues related to cGMP/cGLP regulated customers.
- Develop, maintain and rollout documents and systems used in Bio-Pharmaceutical cGMP/cGLP regulated projects. Documents include standard validation protocol templates, standard operating procedure (SOPs) templates, and functional / design specification templates.
- Defines, designs, plans, schedules, and assists in execution of field office validation work, including but not limited to factory and site acceptance tests, and validation protocols.
- Authors and secures customer approval on all validation-related documentation, to include functional specification, design specification, project implementation plan, test procedures (FAT, SAT), validation protocols, standard operating procedures, summary reports, etc.
- Assists with the execution of validation work by field office personnel and ensures that they are properly trained and qualified.
- Facilitates interaction and communication with field operations to maintain a common reference and provide assistance with Biopharmaceutical related issues.
- Periodically assist Field Operations with Lab/Critical Environments project tasks (design/hardware selection, terminal sizing, start-up/troubleshooting, training etc.) & provide support for Life Science Department initiatives.
Required Knowledge/Skills, Education, and Experience:
- Working knowledge of FDA cGMP validation requirements specific to facility utility systems and software control systems.
- Sufficient formal education and/or experience in a related field to gain an understanding of: Pharmaceutical processes and plant design, cGMP principles, documentation practices and validation requirements including but not limited to software, hardware and electronic records
- Working knowledge of relevant technologies (e.g. HVAC, Clean Room, IT networks, etc).
- 3+ years of experience in writing and executing formal test plans and standard operating procedures.
- Excellent verbal and written communication skills, computer skills, financial skills and effective project management skills. Must be proficient in Microsoft Word.
- Ability to travel up to 30%.
Organization: Smart Infrastructure
Company: Siemens Industry, Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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