Introduction:

This Scope of Work document outlines the responsibilities and expectations for the Senior Project Manager - Capital Project supporting the Site Asset Implementation Plan (AIP) program of a pharmaceutical manufacturing company. The Sr. Project Manager will be responsible for the strategic planning, execution, and delivery of capital investment projects aimed at enhancing production and Packaging lines across the organization.

This role will lead to a portfolio of improvement initiatives designed to increase capacity, reliability, compliance, and cost efficiency while supporting long-term business supply continuity. The purpose of this engagement is to manage and oversee the aspects of the project, including the management of processes for conceptual, preliminary and design phases, management of the construction phases, quality control of documents and reports, adherence to project schedules, management of Change Orders (CO), and representation as the owner's representative.

The position will interface between Operations, Engineering, Quality, Sourcing, and external partners, ensuring projects are delivered safely, on time, and within budget, in accordance with corporate standards and regulatory requirements. By driving modernization, standardization, and technological upgrades of assets, the program plays a critical role in strengthening manufacturing performance and sustaining operational excellence.

Project Background:

The Asset Investment Plan (AIP) Program includes various projects that pursue optimizing efficiency, reliability, and capacity of the business unit in support of sustained product demand and having redundancy for packaging operation. This subprogram focuses on targeted packaging improvement projects to address capacity constraints, asset obsolescence, and operational inefficiencies, while ensuring compliance with quality and regulatory standards. Through strategic capital investments, the program aims to strengthen packaging performance, improve throughput and flexibility, and safeguard long-term supply continuity.

Key Responsibilities:

Manage capital projects from concept through commissioning, start‑up, and close‑out.
Develop detailed project execution plans, schedules, cost estimates, and resource plans.
Ensure project objectives are delivered on time, within scope, budget, and quality standards.
Apply approved project management methodologies, phase‑gate processes, and design standards.
Define and control project scope, ensuring alignment with approved business cases.
Track and control project budgets, commitments, forecasts, and expenditures.
Monitor project schedules, identify critical path risks, and implement recovery plans as needed.
Lead change control processes for scope, cost, and schedule variations.
Leading the development of the conceptual, preliminary and detailed design with the A/E Firm.
Coordinate engineering, sourcing, construction, and commissioning activities.
Review and approve design deliverables, technical specifications, and construction plans.
Ensure constructability, operability, and maintainability are incorporated into project designs.
Support equipment selection, FAT/SAT, installation, and turnover to operations.
Support procurement activities including bid evaluations, contract awards, and execution strategies.
Manage A/E firms, engineering consultants, contractors, and suppliers.
Ensure contractors meet safety, quality, schedule, and contractual obligations.
Review contractor progress, invoices, claims, and change orders.
Enforce site safety standards and promote a strong safety culture throughout the project lifecycle.
Ensure compliance with internal policies, regulatory requirements, and industry standards.
Coordinate quality assurance, inspections, and validation/qualification activities where applicable.
Maintain accurate project documentation and audit readiness.
Identify, assess, and mitigate project‑level risks and dependencies.
Proactively resolve technical, schedule, cost, and execution challenges.
Escalate critical risks and issues to stakeholders with recommended mitigation actions.
Communicate project status, milestones, risks, and decisions to Local Engineering leadership.
Coordinate with operations, maintenance, quality, EHS, sourcing, and finance teams.
Prepare and maintain project dashboards, KPIs, and progress reports.
Support capital governance reviews, steering committees, and management approvals.
Ensure timely project close‑out including financial reconciliation and lessons learned.
Track modifications during construction and equipment activities and ensure changes are captured in engineering documentation as appropriate
Coordinate with QA and Engineering groups to provide approved project documentation for record development
Review invoices from process equipment vendors and construction administrative management submissions
Assist with managing cost expenditures and potential change notices as required
Technical Review change order from process equipment vendors and construction administrative management
Coordination for equipment and systems start-ups and ensure the appropriate documentation of these activities is in place
Coordination with QA on commissioning and qualification activities to ensure the appropriate engineering documentation is available for use
Coordinate with PMO for project document development
Coordinate with Local Engineering to ensure that:
all equipment information is transitioned to PME for long term maintenance
all documentation has been transmitted to Site Engineering group for inclusion in site drawings as-built conditions

Requirements:

Education: BS in Engineering
Experience: Fifteen (15) years of experience on Pharmaceutical Capital projects
Bilingual: English/Spanish
Traveling: 15% is required (Domestic and International)
Professional Engineering license for PR – preferable

Work Location: In person

Exceed, LLC

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