LL01-120325 CQV Project Scheduler

7 days ago

Norwood, Massachusetts, United States Validation & Engineering Group Full time

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 Scheduler – Biotech Facility
Position Summary

The CQV Project Scheduler will lead, coordinate, and oversee all Commissioning, Qualification, and Validation (CQV) activities for a biotechnology manufacturing site in Norwood, MA. This role blends technical CQV expertise with project scheduling, resource planning, and cross-functional coordination. The ideal candidate has strong biotech startup experience, deep understanding of GMP requirements, and proven ability to build and maintain integrated CQV schedules using industry tools—including Smartsheet.

Key Responsibilities
CQV Project Scheduler
  • Lead full lifecycle CQV activities for utilities, equipment, automation, and process systems.
  • Develop and manage CQV execution strategies, resource plans, and deliverables.
  • Oversee and review CQV documentation (URS, DQ, IQ/OQ/PQ protocols, summary reports).
  • Align deliverables with FDA, EU Annex 1, GAMP 5, ICH guidelines, and ISPE Baseline Guides.
  • Manage CQV risk assessments, deviations, change controls, and CAPAs.
  • Support audit readiness and provide subject matter expertise during inspections.
Scheduling & Project Controls
  • Develop, maintain, and optimize integrated CQV schedules using Primavera P6, MS Project, and Smartsheet.
  • Create weekly and monthly look-ahead schedules and critical-path analyses.
  • Track schedule progress, identify constraints, and implement mitigation plans.
  • Coordinate schedule inputs across construction, automation, engineering, and manufacturing.
  • Prepare dashboards, milestone reports, and schedule updates for stakeholders.
Cross-Functional Coordination
  • Facilitate daily and weekly CQV coordination meetings.
  • Manage TOP (Turnover Package) completions, FAT/SAT readiness, and commissioning interfaces.
  • Align CQV milestones with mechanical completion, automation readiness, and process tech transfer.
  • Communicate risks, impacts, and timeline strategies to leadership teams.
Vendor & Contractor Management
  • Coordinate vendor documentation, FAT/SAT execution, and punch list closeout.
  • Manage vendor timelines and verify compliance with CQV requirements.
  • Ensure timely delivery of validated systems.
Qualifications
Education
  • Bachelor's degree in Engineering, Life Sciences, or closely related field.
  • PMP, PMI-SP, or ASQ certification is a plus.
Experience
  • 5–10+ years of experience in CQV, project scheduler and management, or biotech facility startup.
  • Proven experience managing CQV schedules and deliverables using Smartsheet.

  • Demonstrated experience in commissioning and validation of biotech systems:

  • Clean utilities (WFI, Clean Steam, CDA, Nitrogen)

  • HVAC/cleanrooms
  • Upstream/downstream systems
  • Automation/SCADA/DCS systems
  • Strong understanding of cGMP, 21 CFR Part 11, GAMP 5, and regulatory expectations.

Technical Skills

  • Smartsheet expertise required (dashboards, project schedules, workflows, reporting).
  • Proficiency in Primavera P6 and/or MS Project.
  • Ability to interpret engineering drawings, P&IDs, system flow diagrams, and TOP documentation.
  • Strong data analysis, reporting, and documentation skills.
Soft Skills
  • Excellent communication and stakeholder management abilities.
  • Strong organizational, planning, and problem-solving skills.
  • Ability to work independently and in a fast-paced, dynamic environment.
  • High attention to detail and commitment to quality.

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