Pharma Validation Engineer - FDA Compliance & Validation Expert

barrywehmiller; Raleigh (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Barry-Wehmiller Design Group is seeking a Validation Engineer to join our Regulatory Compliance Practice. You will develop and execute validation and FDA compliance documentation for pharmaceutical equipment, traveling to top clients to support design, validation, and start-up activities.

You will collaborate with industry experts to deliver high-quality solutions, while growing technical abilities and leadership skills in a dynamic team environment.

Qualifications

• Minimum of 3 years project experience with validation of automation, packaging, utilities and/or facilities is desired
• Minimum of 3 years project experience in the pharmaceutical or medical device environments is a plus
• Strong technical writing and oral communications
• Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD)
• Willing and able to travel as necessary for project requirements to include but not be limited to project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.

Responsibilities

• FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the pharmaceutical industry
• Assist in the development and execution of QMS procedures, ICH Q1 (Stability Protocols / Reports), CFR 21 Part 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10
• Work with teams to perform investigations and troubleshoot issues related to validation
• Prepare written validation reports
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

Skills

Strong communication

Interpersonal skills

Travel willingness

Technical writing

Team collaboration

Education

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

Tools

AutoCAD

Microsoft Project

Microsoft Office

Job description

Barry-Wehmiller Design Group is seeking a Validation Engineer to join our Regulatory Compliance Practice. You will develop and execute validation and FDA compliance documentation for pharmaceutical equipment, traveling to top clients to support design, validation, and start-up activities.

You will collaborate with industry experts to deliver high-quality solutions, while growing technical abilities and leadership skills in a dynamic team environment.