Summer Engineering Intern
Wade Trim
Validation Engineer
Barry-Wehmiller
full-time
Posted on:
Location Type: Office
Location: Fort Worth • Texas • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment
- Assist in the design of manufacturing processes, help manage projects, and develop facilities
- Handle FAT, SAT, IQ and OQ documentation development and execute on automated systems projects
- 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
- Conduct investigations and troubleshoot issues related to validation
- Prepare written validation reports
Requirements
- A bachelor of science in bioengineering, biomedical engineering, chemical engineering, or a related technical degree
- Strong technical writing and oral communication skills
- Proficiency in Microsoft Office, Microsoft Project, and AutoCAD
- Co-op or project experience with validation of automation, packaging, utilities, or facilities (preferred)
- Co-op or project experience in the pharmaceutical or medical device environments (preferred)
- A willingness to travel for project requirements including installation and start-up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventions
Benefits
- Professional development resources
- Mentorship programs
- A culture of mutual respect and integrity
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
validationFDA compliancemanufacturing processesFAT documentationSAT documentationIQ documentationOQ documentationQMS proceduresICH Q1CFR 21 Part 211
Soft skills
technical writingoral communication