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.
Job Tags
Contract work, For contractors,