CQV Lab Equipment Qualification Engineer

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 coop 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