Validation Engineer

BW Design Group; Raleigh (NC); On-site; USD 75,000 - 120,000; Full time

Job summary

BW Design Group is seeking a Validation Engineer to join our Regulatory Compliance Practice in the United States. You will develop and execute validation protocols for pharmaceutical equipment, travel to top clients to support design and validation activities, and ensure compliance with regulatory standards.

You will perform FAT/SAT/IQ/OQ on automated systems, contribute to QMS procedures, and prepare comprehensive validation reports while collaborating with clients and cross-functional teams to

Qualifications

• Good communication and interpersonal skills across all levels of management, clients, and vendors.
• Minimum of 2 years project experience with validation of automation, packaging, utilities and/or facilities.
• Minimum of 1 year project experience in pharmaceutical, life science, or biotech environments.
• Strong technical writing and oral communications.
• Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD).
• Willingness and ability to travel for project requirements (installation/start-up, client meetings, trainings, 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 nationwide.
• Perform FAT, SAT, IQ and OQ documentation on automated systems in pharma.
• Develop and execute QMS procedures and regulatory documents (ICH Q1 stability protocols, CFR 21 Part 211/820, ICH Q8/9/10).
• Investigate and troubleshoot validation issues with teams.
• Prepare written validation reports.
• Impact client relationships and project outcomes through effective delivery.

Skills

Communication

Interpersonal skills

Technical writing

Microsoft Office

Microsoft Project

AutoCAD

Travel availability

Bioengineering background

Education

B.S. in Bioengineering

Tools

AutoCAD

Microsoft Project

Microsoft Office

Job description

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.

When you join Design Group as a Validation Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

What You’ll Do

You'll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

• Responsible for developing and executing a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. This person will 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. This role will challenge you to be a passionate and successful business family member all while expanding your technical abilities.
• FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the pharmaceutical industry
• 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
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

What You’ll Bring

• Candidates need to possess good communication and interpersonal skills, flexibility with tasks and the ability to interact with all levels of management, clients, and vendors
• Minimum of 2 years project experience with validation of automation, packaging, utilities and/or facilities is desired
• Minimum of 1 year project experience in the pharmaceutical, life science, or biotech 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.

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Validation Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.