Validation Engineer - Experienced

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 communication and interpersonal skills, flexibility with tasks, and the ability to interact with all levels of management, clients, and vendors.
• Travel to top clients across the country to assist in the design of manufacturing processes, help manage projects, develop facilities, and impact the world by conducting themselves with integrity in pursuit of individual and enterprise goals.

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.
• 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.

Qualifications

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