Title: CQV Validation Consultant – Site Master Validation Plan (SMVP) Remediation & Compliance
Location: East of Puerto Rico
Schedule: 100% Onsite
Position Summary
Our client is seeking an experienced CQV Validation Consultant to support the assessment, remediation, and update of multiple Site Master Validation Plans (SMVPs) within a regulated pharmaceutical manufacturing environment.
This role will focus on evaluating and updating validation master planning documentation to ensure compliance with internal procedures, global regulatory expectations, and validation lifecycle requirements. The selected consultant will apply extensive cGMP validation expertise to assess current documentation, identify gaps, verify validation records, and ensure inspection-ready deliverables aligned with quality and compliance standards.
The ideal candidate will possess strong technical writing skills, deep knowledge of validation lifecycle governance, and experience supporting commissioning, qualification, validation, change control, and validation maintenance programs within the pharmaceutical or biotechnology industries.
Key Responsibilities
SMVP Review & Gap Assessment
- Review and assess existing Site Master Validation Plans for multiple manufacturing buildings using established site references and validation frameworks
- Evaluate overall document structure and organization to:
- Simplify content flow
- Reduce redundancy
- Improve readability for cross-functional stakeholders and auditors
- Perform structured gap assessments against:
- Current SOPs
- Validation standards
- Regulatory requirements
- Internal quality expectations
- Conduct cross-site benchmarking activities to evaluate and align validation master planning practices across comparable manufacturing operations
- Identify validation gaps, inconsistencies, and opportunities for compliance improvements
- Ensure validation impact assessments and gap determinations align with applicable validation lifecycle and change control procedures
Validation Status & Records Verification
- Verify inclusion of current approved qualification and validation records
- Confirm completeness and accuracy of inventories related to:
- Facilities
- Classified areas
- Utilities
- Manufacturing equipment
- Computerized systems
- Validation maintenance programs
- Identify:
- Missing records
- Outdated references
- Inconsistent validation documentation
- Ensure validation maintenance activities and documentation align with site periodic monitoring and review requirements
- Organize inventories and supporting references in a clear and traceable format to facilitate audits and regulatory inspections
SMVP Updates & Compliance Alignment
- Update Site Master Validation Plan documentation to accurately reflect the current validated state and lifecycle oversight
- Standardize document sections, structure, terminology, and formatting to improve clarity and consistency
- Ensure all documentation is inspection-ready and suitable for Quality Assurance approval
- Align all updates with:
- Validation lifecycle requirements
- Commissioning and qualification standards
- Change control expectations
- Validation maintenance requirements
Additional Responsibilities
- Serve as the primary point of contact for the SMVP initiative
- Present project updates, findings, risks, and recommendations to senior management and governance forums
- Support alignment, transparency, and communication across stakeholders and leadership teams
- Provide recommendations for identified gaps requiring future execution activities or system requalification efforts
Deliverables
- Updated Site Master Validation Plans for multiple manufacturing buildings
- Gap assessment summary report documenting:
- Findings
- Compliance gaps
- Recommendations
- Updates performed
- Executive-level project presentations and status communications
- Inspection-ready validation documentation aligned with site and global quality standards
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Biotechnology, or a related technical discipline
- Extensive experience in:
- Commissioning, Qualification, and Validation (CQV)
- Validation lifecycle management
- Site Master Validation Plans (SMVPs)
- cGMP regulated environments
- Strong knowledge of:
- Validation lifecycle governance
- Change control systems
- Validation maintenance programs
- Regulatory compliance expectations
- Experience supporting pharmaceutical or biotechnology manufacturing operations
- Strong technical writing and document remediation experience
- Proven ability to assess and interpret validation documentation and quality systems
- Excellent analytical, organizational, and problem-solving skills
- Strong communication and presentation skills with experience interacting with senior leadership
- Ability to work independently and manage multiple priorities in a fast-paced regulated environment
Preferred Experience
- Experience supporting inspection readiness initiatives
- Experience with validation master planning remediation projects
- Familiarity with:
- Commissioning and qualification planning
- Change control processes
- Periodic monitoring programs
- Validation maintenance and review programs
- Experience performing cross-functional collaboration with:
- Quality Assurance
- Manufacturing
- Engineering
- Validation teams
Scope Limitations
This role is focused on document review, assessment, remediation, and compliance alignment activities only.
The following activities are outside the scope of this position:
- Execution or re-execution of commissioning, qualification, or validation testing
- Protocol execution or field activities
- Batch record updates
- Manufacturing procedure revisions
- Control strategy modifications
Work Environment
- 100% onsite role located on the east side of Puerto Rico
- Work will be performed within a regulated pharmaceutical manufacturing environment
- Interaction with cross-functional teams and leadership stakeholders is required
- Candidate must maintain compliance with all applicable quality, safety, and regulatory standards