Jobs in Durham, NC

About the role

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.

What you'll bring

• 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.
• 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.

Benefits

Locations