CQV Validation Engineer - Site Master Validation Plan (SMVP)
Not Disclosed•ContractorOn-site
location_onOn-site
About the Role
Our client is seeking an experienced CQV Validation Consultant to lead the assessment, remediation, and update of multiple Site Master Validation Plans (SMVPs) within a regulated pharmaceutical manufacturing environment. This role is critical for ensuring that validation master planning documentation aligns with internal procedures, global regulatory expectations, and the full validation lifecycle.
The selected consultant will apply deep cGMP expertise to evaluate current documentation, identify compliance gaps, and verify validation records. The primary objective is to transform existing plans into inspection-ready deliverables that simplify content flow, reduce redundancy, and improve readability for cross-functional stakeholders and auditors. This position focuses strictly on document review, assessment, and compliance alignment, serving as the primary point of contact for the SMVP initiative while presenting findings and recommendations to senior management.
Work Environment
This is a 100% onsite role located on the east side of Puerto Rico. The work will be performed within a regulated pharmaceutical manufacturing facility, requiring close interaction with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Validation teams. Candidates must be prepared to maintain strict compliance with all applicable quality, safety, and regulatory standards in a fast-paced environment.
Work location
Work model: On-site
On-site
Key Responsibilities
- check_circleReview and assess existing Site Master Validation Plans for multiple manufacturing buildings
- check_circleVerify inclusion and accuracy of qualification and validation records for facilities and equipment
- check_circleStandardize document sections, structure, and terminology to improve clarity and consistency
- check_circleServe as primary point of contact and present project findings to senior management and governance forums
- check_circleProvide recommendations for identified gaps requiring future execution activities or system requalification
- check_circleUpdate Site Master Validation Plan documentation to reflect current validated states and lifecycle oversight
- check_circlePerform structured gap assessments against current SOPs, validation standards, and regulatory requirements
Requirements
- verifiedBachelor's degree in Engineering, Life Sciences, Pharmacy, Biotechnology, or related technical discipline
- verifiedExtensive experience in Commissioning, Qualification, and Validation (CQV)
- verifiedExtensive experience in Validation lifecycle management
- verifiedExtensive experience with Site Master Validation Plans (SMVPs)
- verifiedExtensive experience in cGMP regulated environments
- verifiedExperience supporting pharmaceutical or biotechnology manufacturing operations
Nice to Have
Experience supporting inspection readiness initiatives. Experience with validation master planning remediation projects. Familiarity with commissioning and qualification planning, change control processes, periodic monitoring programs, and validation maintenance and review programs. Experience performing cross-functional collaboration with Quality Assurance, Manufacturing, Engineering, and Validation teams.
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Skills, education and keywords
Skills: CQV, Site Master Validation Plans, SMVP, CGMP, Validation Lifecycle, Commissioning, Qualification, Change Control, Validation Maintenance, Technical Writing.
Education: Bachelor's degree in Engineering, Life Sciences, Pharmacy, Biotechnology, or related technical discipline required.
Frequently asked questions about CQV Validation Engineer - Site Master Validation Plan (SMVP) at ProQuality Network
What does a CQV Validation Engineer - Site Master Validation Plan (SMVP) at ProQuality Network do?expand_more
Day-to-day, the CQV Validation Engineer - Site Master Validation Plan (SMVP) at ProQuality Network will review and assess existing site master validation plans for multiple manufacturing buildings; verify inclusion and accuracy of qualification and validation records for facilities and equipment; standardize document sections, structure, and terminology to improve clarity and consistency; and serve as primary point of contact and present project findings to senior management and governance forums.
What are the requirements for this CQV Validation Engineer - Site Master Validation Plan (SMVP) role?expand_more
To qualify for the CQV Validation Engineer - Site Master Validation Plan (SMVP) at ProQuality Network position, applicants should have: Bachelor's degree in Engineering, Life Sciences, Pharmacy, Biotechnology, or related technical discipline; Extensive experience in Commissioning, Qualification, and Validation (CQV); Extensive experience in Validation lifecycle management; Extensive experience with Site Master Validation Plans (SMVPs); Extensive experience in cGMP regulated environments; and Experience supporting pharmaceutical or biotechnology manufacturing operations.
Where is the CQV Validation Engineer - Site Master Validation Plan (SMVP) role at ProQuality Network located?expand_more
CQV Validation Engineer - Site Master Validation Plan (SMVP) at ProQuality Network is based in On-site. This is a on-site role.
Is this CQV Validation Engineer - Site Master Validation Plan (SMVP) job remote, hybrid, or on-site?expand_more
ProQuality Network has listed this CQV Validation Engineer - Site Master Validation Plan (SMVP) role as on-site.
How much experience is required for this CQV Validation Engineer - Site Master Validation Plan (SMVP) role?expand_more
Candidates for CQV Validation Engineer - Site Master Validation Plan (SMVP) at ProQuality Network should have senior.
What skills do you need for the CQV Validation Engineer - Site Master Validation Plan (SMVP) role at ProQuality Network?expand_more
Key skills for CQV Validation Engineer - Site Master Validation Plan (SMVP) at ProQuality Network include CQV; Site Master Validation Plans; SMVP; CGMP; Validation Lifecycle; Commissioning; Qualification; and Change Control.
What education is required for CQV Validation Engineer - Site Master Validation Plan (SMVP) at ProQuality Network?expand_more
Educational requirements for this role: Bachelor's degree in Engineering, Life Sciences, Pharmacy, Biotechnology, or related technical discipline required.
What category does the CQV Validation Engineer - Site Master Validation Plan (SMVP) role belong to?expand_more
CQV Validation Engineer - Site Master Validation Plan (SMVP) at ProQuality Network is part of the engineering job category on Recrutus.