Pharma Validation Engineer II – FDA Compliance

Barry-Wehmiller; Clearwater (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Barry-Wehmiller Design Group is seeking a Validation Engineer II to support capital projects and drive FDA validation efforts for pharmaceutical equipment. You will collaborate with industry experts to deliver high-quality validation solutions, traveling to top clients across the country.

You will join a team that values integrity, leadership, and professional growth, with opportunities for mentoring and development in a fast-paced consulting environment.

Qualifications

• Good communication and interpersonal skills; ability to work with all management levels, clients, and vendors.
• 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: MS Office, MS Project, AutoCAD.
• Willing and able to travel as necessary for project requirements.

Responsibilities

• Develop and execute a variety of validation and FDA compliance documents/protocols for pharmaceutical equipment; travel to top clients across the country.
• 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 relationships with clients and team.

Skills

Good communication

Interpersonal skills

Technical writing

Computer skills: MS Office, MS Project

Travel willingness

Education

B.S. in Bioengineering/Biomedical Engineering/Chemical Engineering

Tools

AutoCAD

Job description

Barry-Wehmiller Design Group is seeking a Validation Engineer II to support capital projects and drive FDA validation efforts for pharmaceutical equipment. You will collaborate with industry experts to deliver high-quality validation solutions, traveling to top clients across the country.

You will join a team that values integrity, leadership, and professional growth, with opportunities for mentoring and development in a fast-paced consulting environment.