Senior Validation Engineer (CQV) – Onsite in PA

ELIQUENT Life Sciences

Marietta (PA)

On-site

USD 90,000 - 130,000

Full time

2 days ago

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Benefits offered by this job

Health insurance

401(k) plan with employer match

Paid time off

Job summary

ELIQUENT Life Sciences is seeking an experienced Validation Engineer to join our Mid Atlantic Team onsite in Marietta, PA. You will lead commissioning, qualification and validation activities for isolation systems and CIP skids, developing and executing IQ/OQ/PQ protocols and related reports.

The role requires 5–10 years in regulated manufacturing, familiarity with FDA/cGMP, and ability to read P&IDs and diagrams.

Qualifications

Bachelor's 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 P&IDs, and electrical diagrams

Responsibilities

Commissioning, qualification, and validation of isolators, downflow booths, and CIP skids.
Deliver validation life cycle deliverables: risk assessments, URS, DQ, and equipment validation plans.
Draft, review, approve, and execute IQ/OQ/PQ protocols and reports.
Assist on system implementation tasks as required.
Assist on resolution of system qualification deviations.
Attend periodic meetings and provide updates