Pharma Validation Engineer - Growth, Travel & Compliance

BW Design Group; Raleigh (NC); On-site; USD 85,000 - 125,000; Full time

Job summary

BW Design Group seeks a Validation Engineer to join our Regulatory Compliance Practice. You will work with industry experts to deliver high-quality validation solutions for leading pharmaceutical and medical device clients.

Travel to top clients across the country is required to assist in design of manufacturing processes, manage projects, and develop facilities while maintaining integrity and accuracy.

Qualifications

• Minimum of 3 years project experience with validation of automation, packaging, utilities and/or facilities.
• 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.
• B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.

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 manage projects.
• FAT, SAT, IQ and OQ documentation development and execution on automated systems in the pharmaceutical industry
• Assist in 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 validation issues
• Prepare written validation reports
• Make an impact day-to-day with skills and expertise, strengthening client and team relationships

Skills

Effective communication

Interpersonal skills

Flexibility

Client interaction

Team collaboration

Documentation

Education

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

Tools

Microsoft Office

Microsoft Project

AutoCAD

Job description

BW Design Group seeks a Validation Engineer to join our Regulatory Compliance Practice. You will work with industry experts to deliver high-quality validation solutions for leading pharmaceutical and medical device clients.

Travel to top clients across the country is required to assist in design of manufacturing processes, manage projects, and develop facilities while maintaining integrity and accuracy.