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%.
Siemens Industry, Inc.
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