Senior Project Manager, CQV

CRB; Indianapolis (IN); Hybrid; USD 80,000 - 120,000; Full time

Job summary

An innovative firm is seeking a Sr. Project Manager in CQV to lead cGMP services for Life Sciences clients. This pivotal role requires expertise in compliance and validation, ensuring solutions are delivered right-the-first-time. The successful candidate will excel in communication and leadership, building strong relationships with clients and teams. With the flexibility to work hybrid or remote, this position offers a unique opportunity to impact critical projects in health and safety. Join a company committed to social responsibility and technical excellence, where your contributions will make a difference in the industry.

Benefits

Comprehensive benefits

Competitive salary

Diversity and equal opportunity employment

Disability accommodations

Qualifications

• 8+ years of experience in CQV and compliance within Life Sciences.
• Knowledge of US FDA regulations and validation tools.
• Strong organizational and leadership skills.

Responsibilities

• Develop flexible ETOP packages tailored to client approaches.
• Support cGMP compliance-based services with Trade Partners.
• Write and review CQV documents following 21 CFR standards.

Skills

cGMP compliance

Leadership

Communication

Project Management

Risk Assessment

Education

Bachelor’s Degree in Architecture, Engineering, or related field

Tools

Kaye Validator

Statistical tools

Process improvement tools

Job description

Company Description

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 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 and alternative proteins, our design and construction projects address important issues such as food scarcity and global health.

Job Title: Sr. Project Manager, CQV

CRB is seeking an energetic, self-motivated individual for the role of Sr. Project Manager in CQV. The role involves providing cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients, ensuring solutions are right-the-first-time (RFT), mitigate risks, and meet compliance and timeline objectives. The candidate should demonstrate excellent organizational, communication, and leadership skills, with the ability to build strong relationships with clients and internal teams. The role may be hybrid or remote with travel.

Responsibilities include:

1. Developing flexible ETOP packages tailored to client approaches.
2. Supporting cGMP compliance-based services with Trade Partners and Clients as per the project scope.
3. Writing, reviewing, and approving CQV documents following 21 CFR standards, including SOPs, impact and risk assessments, specifications, FATs, SATs, IOQ/PQs, validation protocols, and commissioning test plans.
4. Supporting onsite and offsite activities such as FATs, SATs, executions, and system walkdowns.
5. Preparing and reviewing reports from Trade Partners on CQV, CV, CSV, and automation activities.
6. Reviewing and approving URS, FRS, DDS, change controls, and FMEA documents.
7. Providing troubleshooting support during execution activities.
8. Training client staff to enhance startup activities.
9. Collaborating with Market Team Leaders to ensure RFT delivery.
10. Planning and executing airflow and smoke visualization studies for ISO and non-ISO spaces.
11. Representing activities in discussions with clients and regulatory agencies.
12. Managing system reviews and requalification activities, assessing impacts using a risk-based approach.
13. Mentoring and guiding commissioning and validation specialists and project leaders.
14. Travel flexibility as needed.
15. Performing other duties as assigned.

Qualifications:

• Bachelor’s Degree in Architecture, Engineering, Construction Management, or related field, or equivalent experience.
• 8+ years of experience in CQV, validation, and compliance within Life Sciences or regulated industries, with knowledge of US and global regulations, cGMP, and SUPAC standards.
• Effective leadership and collaboration skills.
• Experience managing CQV deliverables across multiple projects.
• Strong organizational, interpersonal, presentation, and communication skills.
• Commitment to technical excellence and client/employee experience.
• Knowledge of US FDA (21 CFR) and EU EMEA regulations, ISPE guidelines, and validation tools.
• Experience in writing test plans, protocols, and validation documents.
• Proficiency with statistical, risk assessment, and process improvement tools.
• Familiarity with environmental mapping and validation tools like Kaye Validator.
• Leadership skills to communicate effectively across disciplines.

Additional Information:

All information will be kept confidential per EEO guidelines. CRB is committed to diversity and equal opportunity employment. Employment is contingent on background screening. No unsolicited resumes accepted. Benefits are comprehensive and competitive. For disability accommodations, contact us for assistance.