CQV Engineer

ELIQUENT Life Sciences; Indianapolis (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

ELIQUENT Life Sciences is seeking an experienced Validation Engineer to join the Indianapolis team on a permanent, full-time basis. You will write and revise protocols, execute FAT/SAT/IQ/OQ/PQ, perform temperature mapping, and support Quality, Regulatory and Manufacturing clients.

Candidates should have a engineering/science degree and 2–8 years in validated environments, with FDA/cGMP knowledge.

Qualifications

• Bachelor's degree in engineering, science, or equivalent.
• 2–8 years in validation services in regulated manufacturing.
• Experience executing protocols for process validation, utilities, equipment.
• Knowledge of temperature mapping.
• Familiarity with FDA and cGMP regulations.
• Ability to read P&IDs and electrical diagrams.

Responsibilities

• Write procedures, investigations, protocols, reports and change controls.
• Generate validation lifecycle docs (FAT, SAT, IOQ, PQ) for multiple processes.
• Create installation, operation and performance qualification documents and URS/FRS.
• Perform on-site client support and protocol execution (FAT/SAT/IQ/OQ/PQ).
• Conduct thermal mapping and equipment qualification testing.
• Perform investigations, deviations, risk analysis, and data integrity reviews.
• Summarize studies and assist senior consultants.

Skills

Documentation

Validation protocols

Quality/regulatory support

Client site support

Education

Bachelor's degree in engineering or science

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. We are looking to add someone onto our permanent roster as a Full-time Employee. NO Corp to Corp

.ESSENTIAL DUTIES AND RESPONSIBILITIE

• S: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/requalificatio
• n.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, guidelin
• esand execution plans, automation test plans, engineering design reviews, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specificatio
• ns(FRS), detailed design specifications, factory acceptance test documents (FAT), and/or commissioning test procedure
• s.Performs on site or support work for a client under supervision, including but not limited t
• o:Validation protocol execution for FAT/SAT/IQ/OQ/PQ, thermal mapping of temperature-controlled chambers, warehouses, and sterilization process
• esEquipment Qualification test executi
• onInvestigations and deviatio
• nsRisk analysis, and/
• orData integrity assessments and review of client da
• taExecutes protocols and helps resolve deviations/discrepancies, analyze study data and write summary reports, under supervision of senior consultant

s.QUALIFICATIONS AND REQUIREMENT

• S:Bachelors Degree in engineering, science, or similar field or equivalent experien
• ce2-8 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device indust
• ryExperience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validati
• onExperience with temperature mappi
• ngExperience with many aspects of validati
• onWorking knowledge of FDA and cGMP regulations and documentation practi
• ceAbility to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagra