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BW Design Group · 11 hours ago

Validation Engineer - Experienced

Raleigh, NC

Full-time

Onsite

Mid Level

3+ years exp

BW Design Group is a rapidly growing business that values its employees and fosters an environment for professional development. As a Validation Engineer, you will support capital projects and implement solutions for clients in the pharmaceutical industry, focusing on validation and FDA compliance.

Industrial Automation

Responsibilities

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

Qualification

Validation documentationFDA compliancePharmaceutical industry experienceB.S. in EngineeringTechnical writingProject managementMicrosoft OfficeAutoCADCommunication skillsInterpersonal skills

Required

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 3 years project experience with validation of automation, packaging, utilities and/or facilities is desired

Minimum of 3 years project experience in the pharmaceutical or medical device 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