Senior Project Manager, CQV

CRB is looking for an energetic, self-motivated individual for the role of CQV, Sr. Project Manager. The Commissioning, Qualification & Validation (CQV) Sr. Project Manager will provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. This leadership and guidance will ensure that our Clients have a Rightthe-First Time (RFT) solution that has mitigated risks and met their compliance and timeline objectives. This position requires a high level of organization, communication, and leadership. The qualified candidate should display excellent interpersonal skills to form strong relationships with internal and external clients. They will represent CRB in a professional manner, assist in winning work, and understand how their strategy directly impacts our collective success.ResponsibilitiesDevelop and formalize an ETOP package that includes flexibility for different Client approachesSupports 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 PlansSupport onsite and offsite activities, such as: FATs, SATs, Executions and System WalkdownsPrepare 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 deliveryAbility 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 neededAssess 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 projectsFlexible and willing to travel as neededPerform other duties as assigned