Responsibilities :
- Manage the validation and documentation related to complex computer systems, multiple pieces of equipment / large upgrades / extensive product updates.
- Perform functions of validation engineer draft Validation Plans, Requirements, Test Cases, Summary Reports.
- Manage the systems and processes for change control and coordinate evaluation of proposed changes on laboratory equipment.
- Change management process owner for validation involving new or modified equipment, processes, procedures, and products.
- In this role, validation engineers design and perform validation around lab equipment and computer systems.
- Determine and delegate tasks amongst a team to complete assignment.
- Conduct impact analysis for validation and change management.
- Coordinate teams to complete validation testing activities.
- Manage complete document management and approval through client's process.
- Conducts regulatory impact analysis / assessment and, where warranted, makes recommendations.
- Act as the Subject Matter Expert on various pieces of lab equipment.
Requirements :
- A minimum of a bachelor's degree in an Engineering or Scientific degree and three to seven years industry experience.
- years' experience in GMP regulated environment (with Internship or co-op work experience considered as part of that experience).
- Direct experience authoring / editing / executing validation documents for laboratory equipment (Cat. A, B &C).
- Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including.
- Good Documentation Practice (GDP) in pharmaceutical environment.
- CFR Part .
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