Senior Project Manager

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, 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

Requirements

Qualifications

• 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
• Interpersonal and leadership skills necessary to communicate clearly, and effectively manage qualification/validation activities with all levels of personnel from various disciplines across the organization.