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Senior CQV Specialist

Juncos, PR
mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary
We are seeking an experienced Sr CQV Specialist with strong validation expertise to lead the assessment and update of Site Master Validation Plans (SMVPs) across multiple manufacturing facilities. This role requires deep knowledge of cGMP validation lifecycle, regulatory compliance, and validation governance to ensure alignment with internal standards and global regulatory expectations.  The ideal candidate will drive document-level strategy, cross-functional alignment, and ensure the validated state of systems is accurately represented and maintained.

Key Responsibilities
Project Leadership & Oversight
  • Lead end-to-end execution of SMVP assessment and update activities.
  • Serve as the primary point of contact for project status, risks, and deliverables.
  • Present project updates, findings, and strategic recommendations to senior leadership and governance forums.
  • Ensure alignment of validation documentation across multiple facilities.
SMVP Review & Gap Assessment
  • Evaluate existing Site Master Validation Plans to improve structure, clarity, and usability.
  • Conduct detailed gap assessments against internal SOPs, validation standards, and regulatory requirements.
  • Perform cross-site benchmarking to align validation planning frameworks and best practices.
  • Identify validation impacts and ensure proper classification of gaps.
Validation Status & Documentation Review
  • Verify accuracy and completeness of validation inventories, including:
    • Facilities and utilities
    • Equipment and manufacturing systems
    • Computerized systems
    • Classified areas and support systems
  • Confirm inclusion of current, approved qualification and validation records.
  • Identify inconsistencies, missing documentation, or outdated records.
  • Ensure traceability and structured presentation of validation data.
SMVP Updates & Compliance Alignment
  • Update SMVPs to reflect the current validated state and lifecycle governance.
  • Standardize document structure, terminology, and formatting for clarity and consistency.
  • Ensure documentation is audit-ready and compliant with Quality expectations.
  • Align updates with validation lifecycle requirements and commissioning/qualification practices.
Deliverables
  • Updated Site Master Validation Plans for multiple manufacturing buildings
  • Comprehensive gap assessment report (including findings and recommendations)
  • Executive-level presentations and project updates for leadership stakeholders
Required Qualifications
  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • 20+ years of experience in validation, CQV, or quality within regulated industries (biotech/pharma preferred)
  • Proven experience managing complex validation or compliance-driven projects
  • Strong knowledge of:
    • cGMP regulations
    • Validation lifecycle (process, equipment, utilities, systems)
    • Change control and validation maintenance programs
  • Experience with Site Master Validation Plans (SMVPs) or Validation Master Plans (VMPs)
Key Skills
  • Strong project management and leadership capabilities
  • Excellent analytical and problem-solving skills
  • Ability to interpret and apply regulatory requirements
  • Exceptional written and verbal communication skills
  • Experience working cross-functionally with Quality, Engineering, and Manufacturing teams
  • Ability to present to and influence senior stakeholders
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
 

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