Operational Readiness Scheduler

FITS, LLC; Carolina (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS, LLC in Carolina, Puerto Rico is seeking an experienced professional to lead operational readiness scheduling services for a GMP manufacturing facility. In this role, you will coordinate cross-functional readiness activities, manage integrated schedules, and proactively identify risks to ensure successful startup execution.

The ideal candidate will have a Bachelor's Degree in Engineering or Life Sciences, at least seven years of experience in project scheduling within regulated environments, and advanced proficiency with Primavera P6 and Microsoft Project.

Qualifications

• 7+ years of experience in regulated environments.
• Experience in project scheduling and operational readiness.
• Proficient in Primavera P6 and Microsoft Project.

Responsibilities

• Coordinate operational readiness activities for a GMP facility.
• Facilitate workshops for defining readiness activities.
• Support development and tracking of readiness activities.
• Liaise between Site and Project teams for alignment.
• Monitor and communicate schedule progress and risks.

Skills

Project scheduling

Operational readiness

Cross-functional collaboration

Risk management

Advanced Primavera P6

Microsoft Project

Education

Bachelor's Degree in Engineering or Life Sciences

Job description

Operational Readiness Scheduling Services

WHAT MAKES YOU A FIT

The Technical Part

• Bachelor's Degree in Engineering or Life Sciences with at least seven (7) years of experience in regulated environments.
• Minimum of seven (7) years of experience in project scheduling, project controls, operational readiness, commissioning, qualification, validation, or startup activities within the pharmaceutical, biotechnology, medical device, or other regulated manufacturing industries.
• Advanced proficiency with Primavera P6 / Microsoft Project is required.
• Experience supporting facility startup, operational readiness, process validation, cleaning validation, and GMP manufacturing operations is highly preferred.

The Personality Part

Picture yourself coordinating the operational readiness activities for aGMP manufacturing facility to life. You excel at aligning cross‑functional teams, managing integrated schedules, and proactively identifying risks that could impact startup milestones. You thrive in fast‑paced project environments, communicate effectively with stakeholders, and enjoy turning complex readiness activities into clear, actionable plans. If you are organized, collaborative, and driven by successful startup execution, this role is for you.

AS A PIECE OF FITS, YOU WILL: (The day‑to‑day on the job)

• Facilitate workshops and cross‑functional discussions to define Operational Readiness activities required for startup of new manufacturing operations within an existing site.
• Coordinate readiness activities associated with Process Validation (PV) and Cleaning Validation (CV) Readiness for Dry Products and API‑like operations, including supporting systems such as Tank Farm, Utilities, and Automated Warehouse operations.
• Support the identification, development, and tracking of readiness activities including SOP implementation, training coordination, recruitment readiness, C&Q support activities, Automation/IT readiness, QCL readiness, materials readiness, and EHS requirements.
• Facilitate development of area‑specific Operational Readiness schedules and integrate them into the overall project master schedule.
• Serve as liaison between Site Operations, Operational Readiness teams, and Project teams to ensure alignment of priorities, schedules, milestones, and execution activities.
• Develop, maintain, monitor, and communicate schedule progress, critical milestones, impacts, risks, and changes associated with Operational Readiness activities.
• Identify schedule constraints, execution risks, and opportunities for optimization or continuous improvement to support successful startup execution.
• Prepare schedule metrics, dashboards, reports, and progress updates for project meetings, leadership reviews, and cross‑functional coordination sessions.
• Support post‑C&Q startup activities including Engineering Runs, Demonstration Batches, Process Validation activities, and Cleaning Validation execution readiness.
• Maintain accurate and complete project documentation in alignment with GMP requirements, internal procedures, and project expectations.