CQV – Lab Equipment Qualification Engineer - PH

CQV – Lab Equipment Qualification Engineer - PH4893

Indianapolis, United States | Posted on 07/03/2024

• Industry Pharma/Biotech/Clinical Research
• Job Type Full time
• Work Experience 5+ years
• City Indianapolis
• State/Province Indiana
• Country United States

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 among 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.
• Conduct regulatory impact analysis/assessment and, where warranted, makes recommendations.
• Act as the Subject Matter Expert on various pieces of lab equipment

• 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