Validation Engineer - North Carolina

Validation Engineer (MES)

Location: Durham, North Carolina

Provide computer system validation support for a leading contract development and manufacturing organization (CDMO) specializing in the production of biologics and advanced therapies. We are seeking a flexible and adaptable Validation Engineer (CSV Lead) to represent our team in North Carolina. In this role, you will be responsible for the validation strategy and SDLC documentation for Werum PAS-X MES and Fill/Finish systems, encompassing PLCs, SCADA, MES, and Serialization, within the life sciences manufacturing environment.

Responsibilities

• Develop and execute validation strategies and plans for Werum PAS-X and PLC-based Fill/Finish systems in compliance with regulatory requirements, industry best practices, and company standards.
• Systems may include Werum PAS-X, Siemens and Allen-Bradley PLCs, and Aveva Wonderware SCADA.
• Lead the creation, review, and approval of validation deliverables, including validation plans, protocols, reports, risk assessments, and traceability matrices.
• Collaborate with cross-functional teams to ensure appropriate requirements gathering and mapping for validation activities.
• Conduct and oversee FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and commissioning activities for BAS and Fill/Finish systems.
• Perform risk assessments and impact analyses to identify potential issues and develop mitigation plans.
• Ensure compliance with data integrity requirements and implement measures to maintain data integrity throughout the validation lifecycle.
• Support and provide guidance to the project team regarding CSV (Computer Systems Validation) principles and best practices.
• Liaise with external vendors and contractors to coordinate validation activities and ensure adherence to project timelines.

Skills and Experience

• Bachelor's degree in Engineering, Computer Science, or a related field.
• Minimum of 5 years of experience in CSV and validation within the pharmaceutical or biopharmaceutical industry.
• Strong expertise in validating MES and Fill/Finish systems, including experience with PLCs, SCADA, MES, and Serialization.
• In-depth knowledge of regulatory requirements (FDA, EMA, etc.) and industry standards (GAMP, 21 CFR Part 11) related to CSV and validation.
• Proven experience in developing and executing validation strategies, plans, protocols, and reports.
• Solid understanding of SDLC (Software Development Life Cycle) and familiarity with Agile methodologies.
• Extensive experience with data integrity principles and implementation in CSV activities.
• Excellent problem-solving skills and the ability to analyze complex systems and processes.
• Ability to collaborate effectively with cross-functional teams.
• Proactive mindset with a strong attention to detail and the ability to prioritize tasks effectively.
• Experience working in a regulated GxP environment.
• Previous experience in a leadership or mentoring role is highly desirable.

Joining Valspec as a Validation Engineer (CSV) will provide you with an opportunity to make a significant impact in the validation and CSV processes for cutting-edge life sciences manufacturing systems. If you are a highly motivated and detail-oriented professional with a passion for ensuring compliance and data integrity, we encourage you to apply.

Benefits included.