Pharma Validation Engineer: FDA Compliance & Projects

Barry-Wehmiller Companies Inc.

Carmel (IN)

On-site

USD 95,000 - 130,000

Full time

5 days ago

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Job summary

BW Design Group in the United States is seeking a Validation Engineer to support capital projects and implement solutions for our pharma clients. You will develop and execute validation and FDA compliance documents for pharmaceutical equipment, with travel to top clients across the country to assist in design, qualification, and start-up activities.

The role requires 7+ years of experience in pharma or medical devices, strong technical writing, and the ability to interact with all management

Qualifications

7+ years of project experience in pharmaceutical or medical device environments.
Strong technical writing and oral communication skills.
Willingness to travel to client sites.
Understanding of ICH Q7–11, 21 CFR Parts 210, 211, ISPE Baseline Guides, GAMP5, and ASTM E2500.

Responsibilities

Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment.
Travel to top clients across the country to assist in design of manufacturing processes and facility/start-up activities.
Perform risk assessments, trace matrices, and validation deliverables; prepare validation reports.