Senior Project Manager, CQV

Job Description

• The Sr. Manager will provide guidance & support for daily operations of the CQV team, including internal and external CQV resources, for all regional projects from proposal stage to facility turnover.
• Manage and perform the development of validation protocols, the development of validation studies, data analysis, and compilation of the data and results into final reports.
• Review and approve User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Change controls and equipment, and process Failure Mode and Effects Analysis (FMEA).
• As a subject matter expert, represent these activities in discussions and communications with Clients and regulatory agencies.
• Collaborate in the development of specific CQV plans and ensuring integration with design and construction plans.
• Responsible for the implementation and execution of periodic system reviews and requalification activities as needed.
• Develop execution schedule and planning efforts on all ONE solution projects.
• Interact with regulatory authorities during audits.
• Mentor and train employees, both internal and external, on the CQV approach as it relates to each project.
• Support the development of internal qualification documents.
• Assess the impact on validated status of new systems and changes to existing systems using a quality risk‑based approach.

• Bachelor's Degree in Architecture, Engineering, or Construction Management, or similar degree preferred, or equivalent years of relevant industry experience.
• 9+ years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences and/or regulated industry; sound technical knowledge of both US and global regulatory requirements. Proficient in cGMP and SUPAC standards.
• Demonstrated effective leadership and collaboration skills.
• Direct experience in managing Commissioning, Qualification and Validation deliverables.
• Excellent organizational, interpersonal, presentation, and communication skills.
• Commitment to technical excellence, and to creating world-class experiences for 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 using statistical, risk assessment, and process improvement tools.
• Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator.
• Ability to plan and execute Smoke / Airflow Visualization Studies.
• 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.
• Flexible and willing to travel as needed.

All your information will be kept confidential according to EEO guidelines.

CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category.

Employment is contingent on background screening.

CRB offers a complete and competitive benefit package designed to meet individual and family needs.

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.