Validation Engineer

Who You’ll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

What You’ll Do

• Work individually and in teams to support capital projects and implement solutions for our clients.
• Help our clients make critical changes to improve their performance and realize their most important goals.
• Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.
• 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.
• Maintain strong technical writing and oral communications skills.
• Use strong computer skills (Microsoft Office, Microsoft Project, AutoCAD).
• 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.

What You’ll Bring

• Good communication and interpersonal skills, flexibility with tasks, and the ability to interact with all levels of management, clients, and vendors.
• 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.
• Authoring CAPA's, deviations, SOP's is a plus.

Qualifications

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