CQV Validation Engineer - Site Master Validation Plan (SMVP)

Job Description Title: CQV Validation Consultant – Site Master Validation Plan (SMVP) Remediation & ComplianceLocation: East of Puerto RicoSchedule: 100% OnsiteHave you got the right qualifications and skills for this job Find out below, and hit apply to be considered.Position SummaryOur 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 ResponsibilitiesSMVP Review & Gap AssessmentReview and assess existing Site Master Validation Plans for multiple manufacturing buildings using established site references and validation frameworksEvaluate overall document structure and organization to:Simplify content flowReduce redundancyImprove readability for cross-functional stakeholders and auditorsPerform structured gap assessments against:Current SOPsValidation standardsRegulatory requirementsInternal quality expectationsConduct cross-site benchmarking activities to evaluate and align validation master planning practices across comparable manufacturing operationsIdentify validation gaps, inconsistencies, and opportunities for compliance improvementsEnsure validation impact assessments and gap determinations align with applicable validation lifecycle and change control proceduresValidation Status & Records VerificationVerify inclusion of current approved qualification and validation recordsConfirm completeness and accuracy of inventories related to:FacilitiesClassified areasUtilitiesManufacturing equipmentComputerized systemsValidation maintenance programsIdentify:Missing recordsOutdated referencesInconsistent validation documentationEnsure validation maintenance activities and documentation align with site periodic monitoring and review requirementsOrganize inventories and supporting references in a clear and traceable format to facilitate audits and regulatory inspectionsSMVP Updates & Compliance AlignmentUpdate Site Master Validation Plan documentation to accurately reflect the current validated state and lifecycle oversightStandardize document sections, structure, terminology, and formatting to improve clarity and consistencyEnsure all documentation is inspection-ready and suitable for Quality Assurance approvalAlign all updates with:Validation lifecycle requirementsCommissioning and qualification standardsChange control expectationsValidation maintenance requirementsAdditional ResponsibilitiesServe as the primary point of contact for the SMVP initiativePresent project updates, findings, risks, and recommendations to senior management and governance forumsSupport alignment, transparency, and communication across stakeholders and leadership teamsProvide recommendations for identified gaps requiring future execution activities or system requalification effortsDeliverablesUpdated Site Master Validation Plans for multiple manufacturing buildingsGap assessment summary report documenting:FindingsCompliance gapsRecommendationsUpdates performedExecutive-level project presentations and status communicationsInspection-ready validation documentation aligned with site and global quality standardsQualificationsBachelor’s degree in Engineering, Life Sciences, Pharmacy, Biotechnology, or a related technical disciplineExtensive experience in:Commissioning, Qualification, and Validation (CQV)Validation lifecycle managementSite Master Validation Plans (SMVPs)cGMP regulated environmentsStrong knowledge of:Validation lifecycle governanceChange control systemsValidation maintenance programsRegulatory compliance expectationsExperience supporting pharmaceutical or biotechnology manufacturing operationsStrong technical writing and document remediation experienceProven ability to assess and interpret xaygatp validation documentation and quality systemsExcellent analytical, organizational, and problem-solving skillsStrong communication and presentation skills with experience interacting with senior leadershipAbility to work independently and manage multiple priorities in a fast-paced regulated environmentPreferred ExperienceExperience supporting inspection readiness initiativesExperience with validation master planning remediation projectsFamiliarity with:Commissioning and qualification planningChange control processesPeriodic monitoring programsValidation maintenance and review programsExperience performing cross-functional collaboration with:Quality AssuranceManufacturingEngineeringValidation teamsScope LimitationsThis 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 testingProtocol execution or field activitiesBatch record updatesManufacturing procedure revisionsControl strategy modificationsWork Environment100% onsite role located on the east side of Puerto RicoWork will be performed within a regulated pharmaceutical manufacturing environmentInteraction with cross-functional teams and leadership stakeholders is requiredCandidate must maintain compliance with all applicable quality, safety, and regulatory standards