Pharma Validation Engineer | Regulatory & QA Expert

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

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