Essential Functions:

• Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects.
• Prepare and execute commissioning / validation lifecycle documents.
• Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade.
• Write summary reports for validation and qualification protocols.
• Support project milestones, priorities and deadlines.
• Provide project reporting (budgets, status and scheduling reports)
• Write operating procedures for technical equipment and practices and procedures.
• Perform system and process risk assessments and analyses.
• Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management.
• Develop project specific validation plans and strategy.
• Able to manage and execute multiple projects to meet client’s priorities.
• Provide a practical approach to problem solving.
• Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers.
• Other duties as assigne