LLCQV Project Scheduler

Position: LL01-120325 CQV Project Scheduler

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.

CQV Project Scheduler – Biotech Facility Position Summary

The CQV Project Scheduler will 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 startup experience, deep understanding of GMP requirements, and proven ability to build and maintain integrated CQV schedules using industry tools—including Smartsheet.

Key Responsibilities

• Schedule CQV activities for utilities, equipment, automation, and process systems.
• Develop, manage and schedule CQV execution strategies, resource plans, and deliverables.
• Follow up CQV documentation status (URS, DQ, IQ/OQ/PQ protocols, summary reports).
• Schedule activities for CQV risk assessments, deviations, change controls, and CAPAs.

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/clean rooms
  • 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.

Seniority level:
Mid‑Senior level

Employment type:

Full‑time

Job function:
Strategy/Planning and Information Technology

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