Senior Consultant- Facilities - Allendale, United States - IntePros Consulting

Description

Looking for a Senior Level Facilities & Engineering consultant that will provide a high level assessment of a Cell Therapy Innovator's manufacturing & commercialization site.

The initiative would involve:

• Accessing the current planned manufacturing flow.
• Assessment of their current state (Engineering/Validation).
• Optimization of facility process, Standard Operating Procedures and documentation.
• Build Roadmap for facility engineering and validation optimization - (manufacturing/laboratory equipment).

• 3-5 years Program/Project Management experience.
• 7-10 years Facilities & Engineering experience working within a GMP pharmaceutical or CDMO environment, preferably in Cell Therapy.
• Strong experience in a Regulatory environment in relation to FDA inspection preparation.
• Have adhered to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example, FDA, EMEA, OSHA, HS&E, etc.).
• Manage, plan and schedule discussions with appropriate business and technical stakeholders.
• Provide recommendations and the delivering of a roadmap outlining best practices, processes and standard operating procedures for administrating engineering and validation from both a functional and technical standpoint.
• Understanding of QMS environment and writing and documentation.
• BS Degree in Engineering or Industry related degree