CQV Validation Engineer - Site Master Validation Plan (SMVP)

ProQuality Network; United States; Hybrid; USD 120,000 - 170,000; Full time

Job summary

ProQuality Network in the United States is seeking an experienced CQV Validation Consultant to support assessment, remediation, and updates of Site Master Validation Plans within a regulated pharmaceutical manufacturing environment.

The ideal candidate will have extensive CQV expertise, strong technical writing, and deep knowledge of validation lifecycle governance, change control, and maintenance programs, with responsibilities spanning gaps, documentation updates, and executive communications.

Qualifications

• Bachelor's degree in engineering, life sciences, pharmacy, biotechnology or related technical discipline.
• Extensive CQV experience in regulated pharmaceutical/biotechnology environments.
• Strong knowledge of validation lifecycle governance and change control processes.
• Proven ability to assess, remediate and align validation documentation and quality systems.
• Excellent analytical, organizational, and communication skills for senior leadership interactions.

Responsibilities

• Review Site Master Validation Plans (SMVP) for multiple buildings and assess structure, readability and alignment with SOPs and standards.
• Identify gaps, missing records, outdated references, and opportunities for compliance improvements.
• Update SMVP documentation to reflect current validated state and lifecycle oversight.
• Prepare gap assessment summaries and executive-level presentations; ensure inspection-ready documentation.
• Serve as primary contact for SMVP initiative and coordinate across QA, Manufacturing, and governance forums.

Skills

CQV experience

cGMP

Validation lifecycle governance

Change control

Validation maintenance

Document remediation

Regulatory compliance

Technical writing

Leadership communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Job description

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
• 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
• 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
• 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
• 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
• Updated Site Master Validation Plans for multiple manufacturing buildings
• Gap assessment summary report documenting:
• Findings
• Compliance gaps
• Recommendations
• 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)
• 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
• 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
• 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