Job Description

BioTalent is looking to hire a contract Project Scheduler for a biotech client located in the Norfolk County area. This is a 6–12-month contract that must report on-site daily. There is possibility to extend.

Position Summary

The Project Scheduler will coordinate, and oversee all Commissioning, Qualification, and Validation activities for a biotechnology manufacturing site in Norfolk County, 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 schedules using industry tools— including Smartsheet .

Key Responsibilities

Project Scheduler

• Schedule activities for utilities, equipment, automation, and process systems.
• Develop, manage and schedule 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 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 coordination meetings.
• Manage TOP (Turnover Package) completions, FAT/SAT readiness, and commissioning interfaces.
• Align 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 project scheduling and management, or biotech facility startup.
• Proven experience managing 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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