Senior Project Manager, CQV
CRB
- Cary, NC
- Permanent
- Full-time
- Develop and formalize an ETOP package that includes flexibility for different Client approaches
- Supports cGMP compliance-based services with Trade Partners and Clients as defined by the Project Scope
- Write, Review and Approve CQV documents following established 21 CFR standards, both internally and externally. Document requests could include: Standard Operating Procedures, Impact Assessments, Risk Assessments, Specifications (URS/FRS/DDS), FATs, SATs, IOQ/PQs, Validation Protocols and Commissioning Test Plans
- Support onsite and offsite activities, such as: FATs, SATs, Executions and System Walkdowns
- Prepare and Review reports, both internally and externally, from Trade Partners for completed CQV, CV, CSV and automation activities
- Review & Approve User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Change controls and equipment, and process Failure Mode and Effects Analysis (FMEA).
- Provide investigational & troubleshooting support encountered during execution activities
- Provides technical training to Client staffing to enhance speed of startup activities
- Collaborate with Market Team Leaders to ensure RFT delivery
- Ability to plan and execute Smoke / Airflow Visualization Studies for both Iso & Non-Iso spaces
- As a subject matter expert, represent these activities in discussions and communications with Clients and regulatory agencies • Responsible for the implementation and execution of the periodic system reviews and requalification activities, as needed
- Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach.
- Support, train, mentor, and provide guidance to commissioning and validation specialists/engineers and project leaders in the delivery of C/Q/V services for assigned projects
- Flexible and willing to travel as needed
- Perform other duties as assigned
- Bachelor’s Degree in Architecture, Engineering, or Construction Management, or similar degree preferred, or equivalent years of relevant industry experience.
- 8 + years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences or Regulated Industries; Sound technical knowledge of both US and global regulatory requirements. Proficient in cGMP and SUPAC standards.
- Demonstrated effective leadership and collaboration skills
- Experience in collaborating and managing Commissioning, Qualification and Validation deliverables for one or Multiple Projects
- Excellent organizational, interpersonal, presentation, and communication skills
- Commitment to technical excellence, as well as creating world-class experiences for our clients and employees
- Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations, ISPE Baseline Guide 5 Commissioning and Qualification and ISPE Guideline Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011 • Experience writing commissioning test plans, IOQ/PQ Protocols and Validation Protocols
- Experience using statistical, risk assessment, and process improvement tools.
- Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator