Validation Associate

Validation Associate - Contract - Marietta, PA Are you experienced in validation activities and looking to make an impact within a fast-paced vaccine manufacturing environment? Proclinical is seeking a Validation Associate to support the development, validation, optimization, and maintenance of vaccine manufacturing processes. Primary Responsibilities: This role focuses on ensuring efficiency, consistency, and compliance with regulatory-quality standards. You will play a key part in technical transfers, troubleshooting, and continuous improvement initiatives. Skills & Requirements: Degree in a scientific or technical discipline (e.g., Chemical, Biological, Pharmaceutical, or Pharmaceutical Engineering). Knowledge of process and cleaning validation, CPV/CV, product control strategies, technology transfers, scale‑up, QbD, and statistical analysis. Familiarity with tools such as Statistica, JMP, SAS, Power BI, or similar analytical/statistical software. Understanding of cGMP, ICH Q8-Q11, and EHS requirements. Strong technical writing and communication skills. Ability to work independently and collaboratively within cross‑functional teams. The Validation Associate's responsibilities will be: Design and qualify incoming materials, including chemicals and single-use systems. Validate and monitor manufacturing and cleaning processes. Support Continued Process Verification (CPV) and Cleaning Verification (CV). Monitor critical process parameters and perform process confirmations. Execute process validation and incoming material qualification activities. Maintain validation lifecycle activities, including periodic product reviews and validation plans. Participate in manufacturing investigations, deviations, troubleshooting, and process improvements. Prepare technical documentation and support audits. Develop training materials and deliver technical training sessions. Collaborate with cross-functional teams, including Operations, Quality, Engineering, and MSAT subject matter experts. #J-18808-Ljbffr Proclinical