CQV Engineer

Job Description

Job Description

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.

We at Eliquent are looking for an experienced Validation Engineer to immediately join our Eliquent Consulting : Indianapolis team. The Validation Engineer is an FTE project based role. The Validation Engineer is responsible for the theory and content of validation documents for new cleanrooms and packaging equipment, including utilities qualification, cleanroom qualification, and FAT / SAT / IQ / OQ / PQ of a new packaging line. This will ensure that validation documentation is compliant with site and corporate validation requirements and policies as well as compendial (e.g., USP) and regulatory (e.g., FDA) expectations / regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Writes procedures, investigations, protocols, reports, change controls, etc. to support the Maintenance and Engineering, Validation, Quality, and Regulatory departments.
• Generates validation life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, sterilization, shipping, and processes validation and facilities, utilities, systems, equipment qualification / requalification.
• Writes and revises a variety of Installation, Operation and Performance qualification / verification related documents, including any of all of the following : SOPs, validation / verification master plans, guidelines

and execution plans, automation test plans, engineering design reviews, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications

(FRS), detailed design specifications, factory acceptance test documents (FAT), and / or commissioning test procedures.

QUALIFICATIONS AND REQUIREMENTS :

What We Offer :

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.