Life Science Construction Project Manager Job

TCG Builders, Inc. dba The Core Group located in San Jose, CA seeks a Life Science Construction Project Manager.

* Lead regulatory compliance efforts by ensuring all construction activities adhere to FDA, GMP, and EHS standards, with a focus on life science-specific regulations.
* Manage the integration and validation of MEP systems, including cleanrooms and biosafety labs, ensuring all systems meet industry-specific performance criteria.
* Coordinate the procurement, installation, and commissioning of scientific equipment, working closely with lab managers and scientists to align with operational needs.
* Oversee construction in controlled environments like labs and cleanrooms, implementing strict contamination control measures throughout the project lifecycle.
* Regularly interface with scientific and technical teams to translate complex scientific requirements into actionable construction plans, ensuring alignment with project goals.
* Manage change orders with a focus on regulatory impact, ensuring compliance with life science industry standards and thorough documentation for all changes.
* Develop and oversee the Validation Master Plan (VMP), ensuring all aspects of the project meet validation requirements and collaborate with quality assurance teams for alignment.
* Implement advanced risk management strategies, addressing risks specific to life science projects such as contamination, regulatory non-compliance, and equipment failure.
* Coordinate construction activities with ongoing R&D operations, ensuring minimal disruption and alignment with critical project milestones.
* Oversee project budgeting and financial management, focusing on the specialized costs associated with life science construction, including validation and compliance expenses.
* Collaborate with life science-specific design and engineering teams to ensure designs meet operational, scientific, and regulatory requirements.
* Ensure all construction activities align with validation and quality assurance protocols (IQ, OQ, PQ), collaborating with QA teams to meet quality standards before handover.
* Manage the creation and maintenance of project documentation, tailored to life science facilities, ensuring all documents are audit-ready and compliant with industry standards.
* Other similar duties as assigned.

Resume: HR, 1510 S. Winchester Blvd., San Jose, CA 95128

Master's in Project Management, Civil Engineering, Construction Management or equivalent with 36 months in job offered or any occupation in which the required experience was gained.

Bachelor's in Project Management, Civil Engineering, Construction Management or equivalent with 60 months in job offered or any occupation in which the required experience was gained.

Experience must include: working with Regulatory Compliance including FDA, GMP, & Clean rooms; MEP System Integration and Validation; Scientific Equipment Installation; working with Hazardous Materials Information System; working with house systems including CDA & Vacuum; and Controlled Environment Design.