Senior CQV Engineer

Eliquent Life Sciences, Inc•Marietta, PA

9d•$0 - $80•Onsite

About The Position

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 Mid Atlantic Team onsite in Marietta, PA.

Requirements

Bachelors Degree in engineering, science, or similar field or equivalent experience
5-10 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation
Working knowledge of FDA and cGMP regulations and documentation practice
Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams

Responsibilities

Commissioning, Qualification, and Validation of formulation isolators, wash isolators, downflow booths, and CIP Skids.
Delivery of Validation Life cycle deliverables, such as: Drafting, review, and approval of equipment risk assessments, User Requirement Specifications, Design Qualification, and equipment Validation Plans.
Drafting, review, approval, and execution of SAT/IQ/OQ/PQ protocols and reports.
Assist on system implementation tasks, as required.
Assist on resolution of any system qualification deviations
Attend periodic meetings and provide updates