GMP Biotech Validation Specialist - Hybrid

This individual will support the validation functions on client projects. Apply expertise cross functionally when required and demonstrates transferrable knowledge of validation concepts.

Note: This is an evergreen posting for future positions within our team. If you would like to be considered during the next round of hirings and have the qualifications, please apply.

Generates and executes installation qualification, operational qualification, performance qualification, cleaning validation, and process validation protocols for support of GMP operations
• Reviews equipment documentation, P&IDs, supplier documentation and as-built drawings
• Analyzes validation data, generates Deviation/Investigation Reports and recommending resolutions
• Generates validation summary reports
• Generates equipment SOPs

• Experience related to pharmaceutical, biotech or device manufacturing facilities including commissioning, factory acceptance testing, site acceptance testing, and validation
• Relies on extensive experience and judgement to plan and accomplish tasks and goals
• Detail orientated with excellent written and oral communication skills
• Ability to work independently to solve problems
• Motivated, efficient, self-starter skilled in time management

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