Validation Engineer

Description

• Conduct investigations and troubleshoot issues related to validation
• Prepare written validation reports
• Assist in the design of manufacturing processes, help manage projects, and develop facilities
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team
• 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
• Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment
• Handle FAT, SAT, IQ and OQ documentation development and execute on automated systems projects

Requirements

• Strong technical writing and oral communication skills
• A bachelor of science in bioengineering, biomedical engineering, chemical engineering, or a related technical degree
• Proficiency in Microsoft Office, Microsoft Project, and AutoCAD
• 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
• Co-op or project experience with validation of automation, packaging, utilities, or facilities (preferred)
• Solid interpersonal skills and the ability to interact with management, clients, and vendors

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance