CQV Lab Equipment Qualification Engineer - PH4893

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