CQV Engineer

Eliquent Life Sciences, Inc•Indianapolis, IN

4d•$80,000 - $95,000•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. 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.

Requirements

Bachelors Degree in engineering, science, or similar field or equivalent experience
2-5 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
Experience with temperature mapping
Experience with many aspects of 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

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.
Performs on site or support work for a client under supervision, including but not limited to: Validation protocol execution for FAT/SAT/IQ/OQ/PQ, thermal mapping of temperature-controlled chambers, warehouses, and sterilization processes, Equipment Qualification test execution, Investigations and deviations, Risk analysis, and/or Data integrity assessments and review of client data.
Executes protocols and helps resolve deviations/discrepancies, analyze study data and write summary reports, under supervision of senior consultants.