Ll06-250822 - Project Manager – Cqv Biotech Project

Validation & Engineering Group

Gurabo, PR
Permanente
Tiempo completo

Hace 6 días

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:CQV Project ManagerThe CQV Project Manager is responsible for leading the successful planning, execution, and delivery of Commissioning, Qualification, and Validation (CQV) activities for a biotechnology manufacturing project. This role requires coordination across functional teams—including QA, Engineering, Automation, Operations, and external vendors—to ensure the project achieves compliance with cGMP standards, adheres to schedule and budget constraints, and is aligned with the project's strategic objectives. The ideal candidate has a strong background in CQV delivery within biotech/pharmaceutical environments and experience managing multiple systems or project streams.Key Responsibilities:Project Planning & ExecutionDevelop and maintain the integrated CQV project schedule, including commissioning and qualification activities for process, utility, and facility systems.
Define project scope, milestones, deliverables, and resource requirements across upstream, downstream, and support systems.
Coordinate and lead CQV planning meetings, system handoffs, and readiness reviews.
Track progress against the CQV schedule; report status to stakeholders and leadership.
Drive alignment with construction turnover and engineering deliverables (e.g., URS, design docs, P&IDs, FAT/SAT plans).Team Leadership & Resource ManagementManage CQV team members and third-party contractors/consultants.
Assign workstreams, ensure accountability, and monitor deliverable quality.
Support onboarding and training of new team members and ensure safety and compliance awareness.Stakeholder Communication & ReportingAct as the primary point of contact for CQV-related activities, issues, and updates.
Interface with QA, Facilities, Engineering, Manufacturing, and Automation to align schedules and priorities.
Generate weekly/monthly progress reports, risk logs, and executive summaries.Compliance & Quality OversightEnsure all CQV activities meet regulatory expectations (FDA, EMA), ASTM E2500, ISPE Baseline Guides, and internal procedures.
Facilitate deviation management, change control impact assessments, and documentation reviews.
Ensure that commissioning and qualification documentation supports future inspection readiness and PPQ requirements.Systems in Scope:Upstream and Downstream Biotech Process Equipment
Clean Utilities (WFI, Clean Steam, Process Gases)
Black Utilities (HVAC, Electrical, Water, Compressed Air)
Automation Systems (DeltaV, SCADA, PLCs)
Laboratory and QC Equipment
Facility/Environmental Monitoring SystemsQualifications:Bachelor's degree in Engineering, Life Sciences, or related technical field.
8+ years of experience in the biopharma or biotech industry, with 4+ years in CQV project leadership roles.
Strong knowledge of cGMP manufacturing operations and validation lifecycle requirements.
Demonstrated experience managing complex CQV projects from design through operational readiness.
Familiarity with scheduling software (e.g., MS Project, Primavera P6) and project management tools.Preferred Skills:PMP or equivalent project management certification.
Experience with electronic validation systems (e.g., Valgenesis, Kneat).
Experience supporting greenfield or large capital expansion projects.
Strong interpersonal, organizational, and communication skills.

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