Pharma Validation Engineer — FDA Compliance

Barry-Wehmiller Companies Inc.; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Mentorship program

Career development resources

First Year Experience program

Job summary

Barry-Wehmiller Design Group seeks a Validation Engineer to join a team delivering validation and FDA compliance solutions for pharmaceutical equipment. You will work with industry experts to design, test, and document validation activities across projects nationwide.

You will develop FAT/SAT/IQ/OQ protocols, contribute to QMS procedures, and travel to top clients to ensure project success and client satisfaction while growing your technical leadership in a dynamic environment.

Qualifications

• Minimum of 3 years project experience with validation of automation, packaging, utilities and/or facilities.
• Experience in pharmaceutical or medical device environments is a plus.
• Strong technical writing and oral communications required.
• Willing and able to travel as necessary for project requirements.
• BS in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.

Responsibilities

• Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment.
• FAT, SAT, IQ and OQ documentation development and execution on automated systems.
• Assist in development and execution of QMS procedures and regulatory guidelines.
• Collaborate with teams to perform investigations and troubleshoot validation issues.
• Prepare written validation reports and support project start-up activities.

Skills

Communication skills

Interpersonal skills

Technical writing

Microsoft Office

AutoCAD

Travel willingness

Education

BS in Bioengineering or related

Tools

Microsoft Project

Job description

Barry-Wehmiller Design Group seeks a Validation Engineer to join a team delivering validation and FDA compliance solutions for pharmaceutical equipment. You will work with industry experts to design, test, and document validation activities across projects nationwide.

You will develop FAT/SAT/IQ/OQ protocols, contribute to QMS procedures, and travel to top clients to ensure project success and client satisfaction while growing your technical leadership in a dynamic environment.