CQV Validation Engineer – Life Sciences

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 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.