Subject Matter Expert (SME) – Commissioning, Qualification, and Validation (CQV)
Position Title: Subject Matter Expert (SME) – Commissioning, Qualification, and Validation (CQV)
Availability: Open to U.S. Citizens Local to Puerto Rico
Scope of Service:
Our client is seeking an experienced SME to provide oversight services for the Commissioning, Qualification, and Validation (CQV) of the Capital Project Inspection Modernization specific building. The SME will leverage extensive knowledge of FDA regulatory standards and compliance to analyze, evaluate, and present findings related to CQV activities.
Key Responsibilities:
- Review and approve lifecycle documents, including but not limited to:
- User Requirements Specifications (URS)
- Risk Assessments
- Data Integrity Assessments
- Commissioning and Qualification Plans
- Validation Plans
- Installation and Operational Verification Protocols and Reports
- Provide SME oversight for CQ deviations/events and propose resolutions.
- Review engineering change notices and recommend modifications to qualification strategies.
- Participate in engineering design phases, proposing strategies to ensure successful qualification and startup.
- Anticipate potential pitfalls based on regulatory/compliance guidance.
- Apply Risk-Based Validation approaches aligned with client Standard Operating Procedures (SOPs) and industry standards.
Scope of Work Outline:
The objective of this project is to enable facilities for the future installation of multiple new inspection units and related ancillary equipment. The project involves facility and system modifications to support these new operations in specific building.
Specific Duties:
- Manage and oversee validation operations for the Capital Project Inspection Modernization specific building.
- Review and approve validation documentation such as Validation Master Plans, Performance Qualification (PQ), Requirements Qualification (RQ), and Base Business Protocols.
- Participate in facility and utility expansion design phases, ensuring alignment with corporate and industry standards.
- Act proactively to improve programs, maintain alignment with corporate initiatives, and ensure compliance with current regulatory expectations.
- Serve as the primary SME for the validation program, providing consultation and guidance in areas of expertise.
- Provide technical input to support change controls for manufacturing/distribution equipment, facilities, and systems.
- Exchange information with multidisciplinary teams and other client sites to anticipate and plan for the plant's long-term needs.
- Maintain and ensure compliance with the Validation Program and regulatory expectations.
- Act as a liaison between the Validation Department and other multidisciplinary teams.
- Support the critical Work Order and Change Control Program.
Qualifications:
- Extensive experience in Commissioning, Qualification, and Validation (CQV) within the pharmaceutical or biotech industries.
- Expertise in FDA regulatory standards and compliance.
- Proven ability to review and approve critical validation documentation and manage change controls.
- Experience with facility and utilities expansion projects is preferred.
- Strong communication and leadership skills to work effectively with multidisciplinary teams.
This is an exciting opportunity to contribute as an SME on a high-impact project, ensuring compliance and operational readiness for our client's advanced manufacturing operations.