Validation Engineer

Job Position : Validation Engineer

Location: Indianapolis, IN

Job Type : Full Time

Job Description

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.

Preferred:

• 4+ 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

• 21 CFR Part 11

Thanks,

Raja