Change Control Specialist

Who we are:At MIGSO-PCUBED, our mission is to support delivery of our clients' most important projects and programs. We take pride in delivering world-class project, program, and portfolio management expertise and services to clients in every industry. We are specialists in helping businesses react faster, hit their targets, and maximize value within their project environment. In over 30 years of business, we've helped some of the world's largest companies achieve their most complex goals.We are looking for an experienced and passionate Engineering Change Manager to join our team in Zebulon, NC and support a diverse range of capital projects within pharmaceutical manufacturing and laboratory environments.What you'll do:As an MIGSO-PCUBED Engineering Change Manager, you will play a critical role in governing and controlling engineering design changes across the lifecycle of complex capital projects. You will ensure that all modifications to facilities, systems, and equipment are assessed, approved, documented, and implemented in compliance with regulatory standards and project objectives.You will act as a central coordination point between engineering, quality, validation, construction, and operations teams, ensuring that engineering changes are delivered in a controlled, compliant, and efficient manner without negatively impacting cost, schedule, safety, or product quality.As an MP Consultant, you will have the opportunity to:Work on large-scale pharmaceutical and life sciences capital projectsSupport facility builds, laboratory expansions, and manufacturing programsCollaborate with cross-functional teams across engineering, quality, and operationsDrive best practices in change control, compliance, and project deliveryDevelop strong client relationships while contributing to MP's growthYour responsibilities will include:Engineering Change Control & GovernanceManage the engineering change control process across all project phases (design through commissioning and qualification)Establish and maintain change control procedures aligned with GMP and quality systemsLead or coordinate Change Control Review Boards (CCRB) to review and approve changesImpact Assessment & Risk ManagementEvaluate engineering changes for impact on product quality, regulatory filings, validation status, cost, and scheduleLead structured risk assessments (e.g., FMEA, impact analysis) and mitigation planningEnsure risks are clearly documented, communicated, and managedCross-Functional CoordinationServe as the interface between engineering teams, contractors, quality, validation (CQV), and operationsEnsure stakeholder alignment prior to approval and implementation of changesResolve technical conflicts and drive consensus across teamsDocumentation & Regulatory ComplianceEnsure all engineering changes are properly documented within systems such as TrackWise, Veeva, MasterControl, or EDMSMaintain audit-ready documentation to support regulatory inspections (FDA, EMA, etc.)Ensure compliance with GMP, validation, and quality requirementsProject Integration & ControlsIntegrate engineering changes into project schedules, cost forecasts, procurement plans, and construction activitiesPrevent uncontrolled scope creep and manage design revisions effectivelySupport alignment between engineering changes and overall project delivery strategyCommissioning, Qualification & Validation AlignmentEnsure engineering changes are incorporated into commissioning plans and qualification protocols (IQ/OQ/PQ)Maintain traceability between design changes and validation documentationSupport successful project handover and operational readinessStakeholder Communication & ReportingProvide reporting on change metrics, approval timelines, and risk levelsMaintain dashboards and reporting tools for project and program leadershipCommunicate complex technical changes clearly to both technical and non-technical stakeholdersWhat we're looking for:Bachelor's degree in Engineering or related field (Master's preferred)8-15+ years of experience in engineering change management, project controls, or capital project deliveryStrong experience in pharmaceutical, biotech, or life sciences environmentsTechnical Expertise:Deep understanding of GMP environments and regulatory requirements (FDA, EMA)Familiarity with GAMP5 and validation lifecycle (CQV processes)Knowledge of process equipment, cleanrooms, HVAC, utilities (WFI, clean steam), and automation systemsExperience with engineering and quality systems (TrackWise, Veeva, MasterControl, Documentum, etc.)Project & Risk Management:Strong understanding of capital project delivery across full lifecycle (design to handover)Ability to assess impact of engineering changes on cost, schedule, and scopeExperience supporting large EPC/EPCM programsLeadership & Communication:Proven ability to lead cross-functional teams and governance forumsStrong stakeholder management and influencing skillsExcellent written and verbal communication skillsPreferred Experience:Experience on large capital projects ($100M-$2B+)Background supporting manufacturing facilities, biologics plants, cleanrooms, or lab buildsAbility to manage high volumes of engineering changes in complex environmentsBenefits and PerksAt MP, our people are our pride and joy. We are committed to supporting your career and personal growth:Global networking opportunities across a diverse consulting communityExposure to multiple industries and high-impact projectsPersonalized career coaching and development plansOngoing training, certifications, and learning opportunitiesStructured career progression frameworkInclusive culture built on respect, team spirit, excellence, and commitmentEqual Opportunity StatementMIGSO-PCUBED recognizes the civil right of every person to obtain and maintain employment without discrimination. We have a longstanding policy that no individual may be refused a job, discharged, or discriminated against in any way due to any protected characteristics established by local, state, and federal law. We are committed to equal employment opportunities in all aspects of employment.

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