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 Rightthe-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.

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

• 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 both 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, as well as creating world-class experiences for our 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 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 and use of Kaye Validator

•  

  
  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.

See more jobs at CRB

Apply for this job

Job Description

CRB is looking for an energetic, self-motivated individual for the role of Director, CQV (Commissioning, Qualification and Validation). The Director, CQV is responsible for leading teams of CQV engineers and discipline SMEs, both internal and external, to plan, develop, execute, and manage CQV project lifecycle documents for new equipment, facilities, and processes in compliance with regulatory requirements and quality standards. The Director, CQV will lead the integration and delivery of CQV services on capital projects for our Life Sciences clients, as well as help clients navigate through regulatory requirements, devising and executing strategies that meets client timelines, and assessing / mitigating risk – all while driving leaner processes in order to achieve the end goal. This position requires a high level of organization, communication, leadership, and interpersonal skills that will be used to build strong relationships with internal and external clients.

Responsibilities

· Establish the CQV strategy with client’s Quality / Regulatory teams

· Oversee and develop the creation, revision and execution of Protocols, Reports, and Documents including, but not limited to: CQV Master Plan, Validation Project Plan, Utility and Facility PQs, Drawings, User requirement specifications, SOP’s, Automation Assessments, Impact Assessments Plans

· Develops and administers and/or assists CQV budget throughout the project.

· Develop, implement, and integrate (CQV) strategies aligned with internal standards, as well Client standards into design and construction plans.

· Develop execution schedule supporting Project Lifecycle (P6), with specific focus on developing detailed plans for all CQV phases which support the goals and overall timelines of the project, including Turnover. Ensure that any automation timelines and test requirements are proactively integrated into the overall equipment/system detailed schedule.

· Drive innovative ways to enhance integrated delivery (ONEsolutionTM) projects.

· Ensure that adequate staffing levels are applied (both internally and externally), within the costs constraints of the project to achieve the project goals. Escalate any resource constraints or conflicts proactively.

· Act as subject matter expert (SME) for CQV activities and in developing Project Execution Plans that meet regulatory requirements and industry standards

· Collaborate with cross-functional teams to identify and mitigate risks associated Integrated Project Delivery

· Develop and maintain relationships with key stakeholders for successful project execution.

· Conduct training sessions on CQV principles and best practices, identify opportunities for continuous improvement, and implement changes to optimize team integration of CQV processes.

· Write Scope of Work (SOW) proposals for new and prospective clients based on best practices of QRM (ICH 9,10,11), ISPE Baseline Guide 5, and ASTM E2500

· Responsible for ensuring all regulatory and GxP compliance items related to Validation are satisfied.

· Manage our partners and/or build a group to execute the integrated delivery strategy

· Future – assist in regulatory filings and agency reviews; operational training/staffing for clients

Qualifications

· Bachelor’s Degree in Life Sciences, Engineering, or Construction Management, or similar degree is required.

· 10+ years of Life Science experience in Commissioning, Qualification and Validation, including CSV (computer system validation), with experience in management of pharmaceutical projects. Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable

· Experience in beginning to end project delivery is highly preferred.

· Sound technical knowledge of both US and global regulatory requirements

· Good leadership skills to drive commissioning and qualification execution strategy in different, complex and dynamic projects.

· Flexible individual to manage and adapt to required situations to deliver the project on time and with the right quality to pass the health authorities inspections.

· Knowledge of ISPE guidelines with proven experience on projects. Proven experience in an EMA / FDA regulated environmental with good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.

· Exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S

· Excellent organizational, interpersonal, presentation, and communication skills

· Strongly motivated and well organized

· Comfortable working in a fast-paced and challenging environment

· Advanced knowledge and practical application of ACC, Kneat, Bluebeam and MS Office Suite (PowerPoint, Word and Excel, D365)

· Flexible and willing to travel as needed. Expectation of up to 50% travel depending on the type and location of client engagement.

See more jobs at CRB

Apply for this job

Job Description

Position Summary

The Sr. Application Administrator maintains, monitors, and supports multiple software systems and applications used within the organization. Will function as the primary support resource of systems and/or applications with concurrent users. Responsible for the configuration and customization required to meet the needs of the organization and user base. Ensures application control, integrity, and accessibility via problem-solving, testing, and debugging. Develops and maintains documentation for application access, usage, workflows and procedures. The position is best filled by an energetic, self-motivated individual with a passion for technology, innovation, and problem-solving.

Responsibilities

• Ownership: Serve as the owner of and subject matter expert for multiple applications including but not limited to The Autodesk Construction Cloud, Revit, AutoCAD, Plant3D, Navisworks, Bluebeam, etc.
• Application Management: Manage, install, configure, and maintain a wide range of applications and systems (see above), ensuring optimal performance and availability. Including user management.
• Platform Support: Being the escalation point for trouble shooting from tier one support for multiple platforms as mentioned above.
• Security: Implement and maintain security measures to protect applications and systems from threats and vulnerabilities.
• Monitoring and Optimization: Monitor system performance, identify bottlenecks, and implement optimizations to enhance overall efficiency.
• Patch Management: Keep all applications and systems up-to-date with the latest patches and updates to ensure security and stability.
• Documentation: Create and maintain detailed documentation, including system configurations, procedures, and troubleshooting guides.
• Collaboration: Collaborate with cross-functional teams, including developers, network administrators, and database administrators, to ensure seamless integration and operation of applications.
• Problem Resolution: Respond to and resolve application-related incidents and problems in a timely manner, escalating issues when necessary.
• Capacity Planning: Conduct capacity planning and make recommendations for scaling applications and systems to meet future demands.
• Compliance: Ensure applications and systems adhere to industry regulations and compliance standards.
• Training and Mentorship: Provide guidance and mentorship to junior administrators and support staff.
• Development: When external development is required, oversee all aspects of the development project.
• Travel: As needed to meet the needs of the position, which includes professional development opportunities.
• WORK MODE - Position can be remote but must be US based. 

Qualifications

• Bachelor's degree in Information Technology, Computer Science, or a related field (or equivalent experience).
• More than eight (8) years of experience in application administration, with a strong focus on supporting multiple platforms and systems.
• Proficiency in specific technologies or tools relevant to CRBs software stack.
• Strong understanding of security best practices and experience implementing security measures.
• Excellent problem-solving and troubleshooting skills.
• Effective communication and interpersonal skills.
• Proven ability to work independently and collaboratively in a team environment.
• Experience with [specific industry regulations or compliance standards relevant to CRB].
• Relevant certifications (e.g., Microsoft Certified: Azure Administrator, AWS Certified SysOps Administrator, etc.) a plus.
• Experience with the Autodesk AEC family of products is required.
• Experience with programming and/or regular expressions is preferred.
• Experience with database design principles and management is preferred.
• Understanding of engineering deliverables, documentation methods, and integrated project execution is preferred.

See more jobs at CRB

Apply for this job