Validation & Engineering Group, Inc.
LL01-120325 CQV Project Scheduler
Validation & Engineering Group, Inc., Norwood, Massachusetts, us, 02062
Validation & Engineering Group, Inc. (V&EG) is a leading service supplier that provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and related services.
We are seeking a talented, dedicated individual committed to working 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 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 on 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 a closely related field.
PMP, PMI‑SP, or ASQ certification is a plus.
Experience
5–10+ years of experience in CQV, project scheduling and management, or biotech facility startup.
Proven experience managing CQV schedules and deliverables using Smartsheet.
Demonstrated experience in commissioning and validation of biotech systems including clean utilities (WFI, Clean Steam, CDA, Nitrogen), HVAC/cleanrooms, upstream/downstream systems, and automation/SCADA/DCS systems.
Strong understanding of cGMP, 21 CFR Part 11, GAMP 5, and regulatory expectations.
Technical Skills
Smartsheet expertise (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
Location: Norwood, MA Salary: $85,000.00–$100,000.00 (3 weeks ago)
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We are seeking a talented, dedicated individual committed to working 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 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 on 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 a closely related field.
PMP, PMI‑SP, or ASQ certification is a plus.
Experience
5–10+ years of experience in CQV, project scheduling and management, or biotech facility startup.
Proven experience managing CQV schedules and deliverables using Smartsheet.
Demonstrated experience in commissioning and validation of biotech systems including clean utilities (WFI, Clean Steam, CDA, Nitrogen), HVAC/cleanrooms, upstream/downstream systems, and automation/SCADA/DCS systems.
Strong understanding of cGMP, 21 CFR Part 11, GAMP 5, and regulatory expectations.
Technical Skills
Smartsheet expertise (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
Location: Norwood, MA Salary: $85,000.00–$100,000.00 (3 weeks ago)
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