CRB
Overview
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
Support 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, including: 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, 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 and troubleshooting support during execution activities
Provide technical training to Client staffing to enhance speed of startup activities
Collaborate with Market Team Leaders to ensure RFT delivery
Plan and execute Smoke / Airflow Visualization Studies for Iso and Non-Iso spaces
Represent these activities in discussions with Clients and regulatory agencies
Implement and execute periodic system reviews and requalification activities, as needed
Assess impact to validated status of new systems and changes using a quality risk-based approach
Support, train, mentor, and provide guidance to commissioning and validation specialists/engineers and project leaders
Flexible and willing to travel as needed
Perform other duties as assigned
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 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 and 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 and ISPE guidelines for delivery of facilities, systems, and equipment
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
Interpersonal and leadership skills to communicate clearly and manage qualification/validation activities with all levels of personnel
Additional Information All your information will be kept confidential according to EEO guidelines. CRB is committed to hiring and retaining a diverse workforce and is an Equal Opportunity/Affirmative Action Employer. Employment is contingent on background screening.
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.
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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
Support 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, including: 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, 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 and troubleshooting support during execution activities
Provide technical training to Client staffing to enhance speed of startup activities
Collaborate with Market Team Leaders to ensure RFT delivery
Plan and execute Smoke / Airflow Visualization Studies for Iso and Non-Iso spaces
Represent these activities in discussions with Clients and regulatory agencies
Implement and execute periodic system reviews and requalification activities, as needed
Assess impact to validated status of new systems and changes using a quality risk-based approach
Support, train, mentor, and provide guidance to commissioning and validation specialists/engineers and project leaders
Flexible and willing to travel as needed
Perform other duties as assigned
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 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 and 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 and ISPE guidelines for delivery of facilities, systems, and equipment
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
Interpersonal and leadership skills to communicate clearly and manage qualification/validation activities with all levels of personnel
Additional Information All your information will be kept confidential according to EEO guidelines. CRB is committed to hiring and retaining a diverse workforce and is an Equal Opportunity/Affirmative Action Employer. Employment is contingent on background screening.
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.
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