Senior Project Manager, CQV

Senior Project Manager, CQV

CRB's over 1,100 expert professionals drive innovative, life-changing and life-saving solutions for manufacturers in the life sciences and food and beverage industries. Our mission, vision, and core values put client satisfaction and employee experience at the center of everything we do.

As an AEC Firm we proudly specialize in industries that inherently carry important social responsibility - we recognize our impact and influence in the communities we serve and pursue corporate responsibility through the lens of people, community, and planet. From oncology and rare disorders to COVID-19 or alternative proteins, our design and construction projects are pioneering solutions addressing important issues such as food scarcity and global health.

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 Right the 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.

This position has the opportunity to be hybrid or remote with travel.

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

Qualifications

Qualifications

Additional Information

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 / Affirmative Action 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 does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails.

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.