Validation Engineer
About The Position
The Validation Engineer joins Design Group’s Regulatory Compliance Practice and works with industry experts, technical specialists, and clients to deliver validation and FDA-compliance solutions. The role supports capital projects, helps clients improve performance, and contributes to the design of manufacturing processes and facilities. The engineer develops and executes validation documentation and protocols for pharmaceutical equipment, supports project management, investigates and troubleshoots validation issues, and prepares written validation reports. Travel to client sites across the country is required as project needs dictate. The position offers professional development resources and mentorship, including a First Year Experience program, Individual Development Plans, and Career Path resources.
Requirements
- Bachelor of Science in Bioengineering, Biomedical Engineering, Chemical Engineering, or a related technical field.
- Good communication and interpersonal skills, flexibility with tasks, and ability to interact with all levels of management, clients, and vendors.
- Strong technical writing and oral communication skills.
- Strong computer skills, including Microsoft Office, Microsoft Project, and AutoCAD.
- Willingness and ability to travel as required by project needs.
Nice To Haves
- At least 3 years of project experience with validation of automation, packaging, utilities, and/or facilities.
- At least 3 years of project experience in pharmaceutical or medical device environments.
Responsibilities
- Develop and execute validation and FDA-compliance documents and protocols for pharmaceutical equipment.
- Develop and execute FAT, SAT, IQ, and OQ documentation for automated systems in the pharmaceutical industry.
- Assist in developing and executing QMS procedures and protocols or reports related to ICH Q1, CFR 21 Part 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10.
- Work with teams to investigate and troubleshoot validation-related issues.
- Prepare written validation reports.
- Support capital projects and implement client solutions, including work related to manufacturing processes, facilities, and project management.
- Travel as needed for project installation and start-up activities, client and company meetings, training, and industry events.
Benefits
- Professional development resources and mentorship.
- First Year Experience program.
- Individual Development Plans.
- Career Path resources and tools.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
