Senior Project Manager, Cqv

Job Description
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.
Responsibilities
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, RESUME, 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 supportencountered 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