ZipRecruiter
Senior Project Manager, CQV
ZipRecruiter - San Diego, California, United States, 92189
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Overview
Job 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 specialize in industries that inherently carry social responsibility. We recognize our impact and influence in the communities we serve and pursue corporate responsibility through people, community, and planet. Our projects address issues such as food scarcity and global health, including oncology, rare disorders, COVID-19, and alternative proteins. Position Overview
CRB is seeking an energetic, self-motivated Sr. Project Manager for CQV (Commissioning, Qualification & Validation). The role provides cGMP leadership and guidance for CQV services to our Life Sciences clients, ensuring solutions are right-the-first-time (RFT), mitigating risks, and meeting compliance and timeline objectives. The ideal candidate will demonstrate excellent organization, communication, and leadership skills, and foster strong relationships with clients and internal teams. This position offers flexibility for hybrid or remote work with travel. Responsibilities
Develop and formalize an ETOP package adaptable to various client approaches. Support cGMP compliance-based services with Trade Partners and Clients as per project scope. Write, review, and approve CQV documents following 21 CFR standards, including SOPs, impact and risk assessments, specifications, 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 from Trade Partners on CQV, CV, CSV, and automation activities. Review and approve URS, FS, DS, change controls, and FMEA documents. Provide troubleshooting support during execution activities. Offer technical training to client staff to accelerate startup activities. Collaborate with Market Team Leaders to ensure RFT delivery. Plan and execute airflow and smoke visualization studies for ISO and non-ISO spaces. Represent activities in discussions with clients and regulatory agencies as a subject matter expert. Manage periodic system reviews and requalification activities, assessing impacts using a risk-based approach. Support, mentor, and guide commissioning and validation specialists/engineers and project leaders. Willingness to travel as needed. Perform other duties as assigned. The pay range in California is $150,000-$180,000, based on experience. Qualifications
Bachelor’s Degree in Architecture, Engineering, Construction Management, or related field, or equivalent experience. 8+ years of experience in Commissioning, Qualification, 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. Excellent organizational, interpersonal, presentation, and communication skills. Strong technical knowledge of US FDA regulations (21 CFR 210, 211, 810), EU EMEA regulations, ISPE guidelines, and validation tools. Experience in writing test plans, protocols, and validation documentation. Familiarity with statistical and risk assessment tools, environmental mapping, and validation software. Leadership skills to effectively communicate and manage qualification/validation activities across disciplines. Additional Information
All information will be kept confidential according to EEO guidelines. CRB is committed to diversity and equal opportunity employment. Employment is contingent on background screening. We do not accept unsolicited resumes from search firms or agencies. CRB offers comprehensive benefits. If accommodations are needed to complete the application, please contact us.
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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 specialize in industries that inherently carry social responsibility. We recognize our impact and influence in the communities we serve and pursue corporate responsibility through people, community, and planet. Our projects address issues such as food scarcity and global health, including oncology, rare disorders, COVID-19, and alternative proteins. Position Overview
CRB is seeking an energetic, self-motivated Sr. Project Manager for CQV (Commissioning, Qualification & Validation). The role provides cGMP leadership and guidance for CQV services to our Life Sciences clients, ensuring solutions are right-the-first-time (RFT), mitigating risks, and meeting compliance and timeline objectives. The ideal candidate will demonstrate excellent organization, communication, and leadership skills, and foster strong relationships with clients and internal teams. This position offers flexibility for hybrid or remote work with travel. Responsibilities
Develop and formalize an ETOP package adaptable to various client approaches. Support cGMP compliance-based services with Trade Partners and Clients as per project scope. Write, review, and approve CQV documents following 21 CFR standards, including SOPs, impact and risk assessments, specifications, 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 from Trade Partners on CQV, CV, CSV, and automation activities. Review and approve URS, FS, DS, change controls, and FMEA documents. Provide troubleshooting support during execution activities. Offer technical training to client staff to accelerate startup activities. Collaborate with Market Team Leaders to ensure RFT delivery. Plan and execute airflow and smoke visualization studies for ISO and non-ISO spaces. Represent activities in discussions with clients and regulatory agencies as a subject matter expert. Manage periodic system reviews and requalification activities, assessing impacts using a risk-based approach. Support, mentor, and guide commissioning and validation specialists/engineers and project leaders. Willingness to travel as needed. Perform other duties as assigned. The pay range in California is $150,000-$180,000, based on experience. Qualifications
Bachelor’s Degree in Architecture, Engineering, Construction Management, or related field, or equivalent experience. 8+ years of experience in Commissioning, Qualification, 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. Excellent organizational, interpersonal, presentation, and communication skills. Strong technical knowledge of US FDA regulations (21 CFR 210, 211, 810), EU EMEA regulations, ISPE guidelines, and validation tools. Experience in writing test plans, protocols, and validation documentation. Familiarity with statistical and risk assessment tools, environmental mapping, and validation software. Leadership skills to effectively communicate and manage qualification/validation activities across disciplines. Additional Information
All information will be kept confidential according to EEO guidelines. CRB is committed to diversity and equal opportunity employment. Employment is contingent on background screening. We do not accept unsolicited resumes from search firms or agencies. CRB offers comprehensive benefits. If accommodations are needed to complete the application, please contact us.
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