6316 - Capital Project Manager – GMP Manufacturing & Construction / Project Manager

DescriptionVerista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.Company Culture Guidelines & Values:We empower and support our colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.We constantly acquire new skills and learn from our experiences to enhance our collective expertiseThe Capital Project Manager is responsible for the end‑to‑end delivery of capital projects within a GMP-regulated manufacturing environment, from project initiation through commissioning, qualification, and handover. This role requires hands-on construction management capability, strong cross‑functional leadership, and demonstrated experience delivering manufacturing, utilities, and infrastructure projects in compliance with GMP, quality, and regulatory requirements.The Project Manager is accountable for scope, schedule, cost, quality, safety, and risk, and serves as the primary interface between Engineering, Construction, Quality, Validation, Operations, and external partners.Capital Project Manager Responsibilities:Project Leadership & GovernanceLead capital projects in accordance with enterprise capital governance and phase‑gate requirements Act as single point of accountability for project execution, decision-making, and escalationAlign project objectives with business needs, operational readiness, and regulatory expectationsProvide clear and proactive communication to senior leadership and stakeholdersScope, Cost & Schedule ManagementDefine and manage project scope, ensuring alignment with approved business requirementsDevelop, maintain, and control integrated cost and schedule baselinesLead change management, trend analysis, and forecast‑at‑completion reporting Ensure timely identification and mitigation of project risks and constraintsDesign & Engineering Oversight (GMP Environment)Oversee development and approval of URS, Basis of Design, specifications, and drawingsEnsure GMP design principles are embedded (material/personnel flow, segregation, cleanability)Facilitate GMP and constructability design reviews with Quality and OperationsEnsure documentation supports validation, regulatory inspection, and lifecycle managementConstruction ManagementLead construction planning and execution, including site logistics, sequencing, and safetyManage contractors, CM firms, and vendors to ensure efficient and compliant deliveryOversee daily/weekly construction progress, field change control, and issue resolutionEnforce GMP construction controls: segregation, cleanliness, and controlled turnoverCommissioning, Qualification & ValidationEnsure structured system turnover from construction to commissioningCoordinate commissioning activities to support qualification readinessPartner with Validation and Quality to support IQ/OQ/PQ executionIssue complete, audit‑ready turnover packages to Operations and QualityRegulatory & Quality ComplianceEnsure alignment with site change control and regulatory impact assessment requirementsSupport regulatory filings, inspections, and audits as requiredMaintain project documentation in a state of inspection readinessCloseout & Operations ReadinessDeliver complete project closeout, including financial, technical, and regulatory documentationSupport training, SOP updates, asset capitalization, and maintenance handoverCapture and communicate lessons learned to improve future project deliveryProject Initiation & PlanningApproved Project Charter and Capital AuthorizationStakeholder & Communication PlanGMP Impact Assessment and Change Control initiationInitial Cost Estimate and Level 1–2 ScheduleDesign & Pre‑ConstructionUser Requirements Specification (URS)Basis of Design (BOD)GMP Design Review PackagesClass 3/2 Cost EstimatesIntegrated Master ScheduleProcurement and long‑lead strategy Construction & ExecutionConstruction Execution Plan and Site Logistics PlanContractor contracts and bid evaluation documentationWeekly and monthly cost/schedule reportsChange orders and field change documentationGMP construction compliance recordsCommissioning, Qualification & ValidationSystem Turnover PackagesCommissioning Plans and ReportsIQ/OQ/PQ support documentationTraceability between URS and qualificationTurnover & CloseoutAs‑Built DrawingsAsset Handover and Operations Readiness PackageFinal Cost Report and Forecast Variance AnalysisLessons Learned ReportIn‑Service Date (ISD) approval documentation Requirements:Bachelor’s degree in Engineering, Construction Management, or related fieldSignificant experience delivering capital projects in GMP manufacturing environmentsStrong construction execution and contractor management backgroundDemonstrated knowledge of:GMP facility design and construction practicesCommissioning and qualification processesCapital cost control, forecasting, and schedulingProven ability to lead cross‑functional teams in regulated environmentsKey Competencies:Capital project delivery leadershipGMP and regulatory awarenessConstruction execution and problem solvingCost, schedule, and risk managementClear executive‑level communicationFor US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.*Verista is an equal opportunity employer.National (US) Range: $107,800 USD - $168,000 USDBenefitsWhy Choose Verista?High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementVerista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.For more information about our company, please visit us at Verista.com