Validation Associate

Validation Associate

Join a fast-paced vaccine manufacturing environment to make a significant impact. This role supports the development, validation, optimization, and maintenance of vaccine manufacturing processes, ensuring efficiency, consistency, and compliance with regulatory-quality standards.

Primary Responsibilities

• 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.

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.