Hello Connections!
Pharmatek is actively hiring for CQV – Lab Equipment Qualification Engineer at Indianapolis, IN.
Responsibilities:
Lead a Team through the qualification effort of making a lab and its equipment compliant to regulations and company procedures
• 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 five to ten years industry experience.
Preferred:
• 7+ 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)
• Expert knowledge of FDA regulations, ISPE guidelines and ISO standards including:
• Good Documentation Practice (GDP) in the pharmaceutical environment
• 21 CFR Part 11
Interested candidates apply here: https://lnkd.in/deuY2nFf
#CQV #medicaldevice #pharmaceutical #manufacturing
