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.