LL01-120325 CQV Project Scheduler
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Job Location:
Norwood, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 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 toolsincluding Smartsheet.
Key Responsibilities
CQV Project Scheduler
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
Bachelors degree in Engineering Life Sciences or closely related field.
PMP PMI-SP or ASQ certification is a plus.
Experience
510 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.
Key Skills
- Primavera
- Construction Experience
- Project Scheduling
- Primavera P6
- Risk Analysis
- Cost Control
- Project Server
- Schedule Management
- Earned Value Management
- Project Planning
- Project Management Software
- Microsoft Project
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
