• Maintaining and verifying chamber monitoring tracking information and confirming readiness for routine and quarterly monitoring activities.
• Reviewing and supporting change controls related to chamber updates and Yokogawa panel replacements, including coordinating assessments, approvals, and communication of monitoring gaps.
• Partnering with chamber owners, facilities, and service providers to support monitoring readiness, equipment status, and required documentation.
• Serving as a business lead and subject matter resource for COMET change control processes, including supporting user adoption, issue resolution, system testing, process improvements, and stakeholder communication.
• Acting as a single point of contact for assigned change controls, including pre-change planning, record assignment, assessment initiation, follow-up, board review coordination, approvals, extensions, amendments, and closure tracking.
• Maintaining reports, dashboards, and periodic updates for change controls, NC/CAPA activities, investigations, action items, and compliance metrics.
• Supporting monthly financial close and reporting activities, ensuring accurate and timely financial information.
• Developing and managing capital and expense budgets, forecasts, scenario planning, and variance analyses.
• Monitoring project performance against forecasts, updating budgets during planning cycles, and supporting on-time, within-budget execution.
• Building dashboards, analyzing performance trends, and providing insights to support financial, operational, and strategic decision-making.
• Collaborating with Finance, Operations, PMO, Supply Chain, Quality, and scientific teams to improve planning, controls, standardization, and execution.

• Bachelor’s degree in Science, Engineering, Finance, Business, or a related field is required with at least 4 years of industry experience OR a Master’s degree /MBA (or equivalent degree) with at least 2 years of industry experience OR PhD with 1 year of industry experience.
• Experience supporting change control, quality systems, or regulated operations in a pharmaceutical, biotech, or related environment is required.
• Strong understanding of operational coordination, compliance processes, and record management is required.
• Experience with budgeting, forecasting, variance analysis, and financial reporting is required.
• Ability to manage multiple priorities and coordinate activities across cross-functional teams is required.
• Strong analytical, organizational, and problem-solving skills are required.
• Strong written and verbal communication skills are required.
• Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and OneNote, is required.
• Experience developing reports, dashboards, or performance metrics is required.
• Experience with COMET or similar electronic change control systems is preferred.
• Experience with chamber monitoring, facilities coordination, or equipment change activities is preferred.
• Knowledge of NC/CAPA processes and compliance reporting is preferred.
• Experience with data visualization tools such as Power BI, Tableau, or Spotfire is preferred.
• Ability to identify process improvements and drive standardization is preferred.
• Project management experience in development or commercial operations is preferred.

Required Skills:

Preferred Skills: