Pharma Validation Engineer III - FDA Compliance + Travel

Barry-Wehmiller; Carmel (IN); Sur place; USD 110 000 - 140 000; Plein temps

Résumé du poste

Barry-Wehmiller Design Group in Carmel, IN is seeking a Validation Engineer III to join our Regulatory Compliance Practice. You will collaborate with industry experts to develop and execute pharmaceutical validation and FDA compliance documents, and you’ll travel to top clients across the country.

You will work with teams on qualification data, risk assessments, and validation reports, while growing your technical leadership and effective communication within a large, global engineering firm.

Qualifications

• Candidates have 7+ years of project experience in pharma or medical device environments.
• Strong technical writing and verbal communication skills are required.
• Travel to client sites is necessary for project execution.
• Experience with FDA validation and ICH guidelines is preferred.
• BS in a relevant engineering field is required.

Responsabilités

• Develop and execute validation and FDA compliance documents for pharmaceutical equipment.
• Establish user requirements and perform risk assessments for systems and processes.
• Create validation reports and maintain trace matrices.
• Lead investigations and troubleshoot validation-related issues.
• Coordinate project planning, scheduling, and client communications.
• Collaborate with cross-functional teams on qualification activities.
• Support installation, start-up activities, and vendor interactions.

Connaissances

Communication

Teamwork

Pharma experience

Technical writing

Travel readiness

Formation

B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree

Outils

Microsoft Office

Microsoft Project

AutoCAD

Description du poste

Barry-Wehmiller Design Group in Carmel, IN is seeking a Validation Engineer III to join our Regulatory Compliance Practice. You will collaborate with industry experts to develop and execute pharmaceutical validation and FDA compliance documents, and you’ll travel to top clients across the country.

You will work with teams on qualification data, risk assessments, and validation reports, while growing your technical leadership and effective communication within a large, global engineering firm.