Senior CQV Project Leader
2 weeks ago
CRB is seeking a dynamic and proactive individual for the position of Senior Project Manager in Commissioning, Qualification & Validation (CQV). The CQV Project Manager will deliver cGMP expertise and oversight for the integration and execution of CQV services tailored for our Life Sciences clientele.
Key Responsibilities
As a leader in this role, you will ensure that our clients receive a Right-the-First-Time (RFT) solution that effectively mitigates risks while fulfilling compliance and timeline requirements. This position demands exceptional organizational, communication, and leadership skills. The ideal candidate will possess outstanding interpersonal abilities to cultivate robust relationships with both internal and external stakeholders.
In this capacity, you will:
- Develop and formalize an Enhanced Technical Operations Package (ETOP) that accommodates various client methodologies.
- Support cGMP compliance services in collaboration with Trade Partners and Clients as outlined in the Project Scope.
- Draft, review, and approve CQV documentation in accordance with established 21 CFR standards, both internally and externally.
- Manage document requests including Standard Operating Procedures, Impact Assessments, Risk Assessments, Specifications (URS/FRS/DDS), FATs, SATs, IOQ/PQs, Validation Protocols, and Commissioning Test Plans.
- Facilitate onsite and offsite activities such as FATs, SATs, executions, and system walkdowns.
- Prepare and review reports from Trade Partners regarding completed CQV, RESUME, CSV, and automation activities.
- Review and approve User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), change controls, and process Failure Mode and Effects Analysis (FMEA).
- Provide troubleshooting and investigational support during execution activities.
- Deliver technical training to client personnel to expedite startup processes.
- Collaborate with Market Team Leaders to ensure successful RFT delivery.
- Plan and execute Smoke / Airflow Visualization Studies for both ISO and Non-ISO environments.
- Act as a subject matter expert in discussions with clients and regulatory bodies.
- Oversee the implementation and execution of periodic system reviews and requalification activities as necessary.
- Assess the impact on validated status due to new systems and modifications to existing systems using a quality risk-based approach.
- Support, mentor, and guide commissioning and validation specialists/engineers and project leaders in delivering C/Q/V services for assigned projects.
- Exhibit flexibility and willingness to travel as required.
- Perform additional duties as assigned.
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