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 a  GMP 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.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?