AIS Professional & Technical Solutions (AIS) is a multidisciplinary consulting firm providing strategy planning, project management, engineering, and design services to the pharmaceutical, industrial, commercial, and clinical sectors. For more than two decades, AIS has supported established organizations by delivering comprehensive, enterprise‑wide solutions that integrate industry best practices and minimize operational risk.
We are seeking a highly skilled Packaging Capital Program Manager to support Capital Projects within a pharmaceutical manufacturing environment. Its core purpose is to ensure the strategic planning, execution, and delivery of capital investment projects are performed successfully across the organization. This role leads 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 projects, 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 acts as a key 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 upgrades to asset technology, the program plays a critical role in strengthening manufacturing performance and sustaining operational excellence.
Will act as the primary quality liaison between engineering, construction, and operations.
Your expertise will help us innovate continuously while maintaining high standards of quality and efficiency—making a tangible impact every day!
Key Roles & Responsibilities
1. Program Management
- Manage capital projects from concept through commissioning, start‑up, and close‑out.
- 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.
- Coordinate with operations, maintenance, quality, EHS, sourcing, and finance teams.
- 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.
2. Project Management
- 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, within budget, and in line with 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.
- 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.
- 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.
- Coordinate with PMO for project document development.
3. Quality & Regulatory Compliance
- 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.
4. Document Control & Turn-over
Coordinate to ensure that:
- All equipment information is transitioned to Site Engineering for long-term maintenance.
- All documentation has been transmitted to the Site Engineering group for inclusion in the site drawings as-built conditions.
- All documentation has been transmitted to the Quality Assurance group for compliance with quality and regulatory procedures.
- All project information is transitioned to PMO.
Required Qualifications & Experience
- Bachelor of Science in Engineering (Mechanical, Industrial, Manufacturing, Systems, or Electrical).
- Minimum 10+ years of professional engineering and project management experience in high-speed pharmaceutical manufacturing, packaging, or industrial processing environments.
- Bilingual (English/Spanish).
Preferred Skills & Certifications
- Capital Equipment Lifecycles: Expertise in all phases of project execution from initial budget scoping and pre-planning to procurement, vendor coordination, installation, and final start-up.
- Financial Acumen: Proven ability to build business cases, develop cost forecasts, manage multi-million-dollar budgets, and track project ROI.
- Technical Acumen: Ability to understand technical details, read construction/engineering schematics, and guide stakeholders (e.g., process and capital engineers).
- Risk & Timeline Management: Capability to identify critical paths, manage extreme complexities, mitigate bottlenecks, and keep geographically dispersed teams on schedule.
- Communication & Governance: Strong communication skills to report to executive stakeholders, negotiate with external manufacturing vendors, and ensure compliance with safety and sanitary design codes.
- Project Management Professional (PMP) certification is a plus.
Physical & Work Requirements
- Ability to sit for extended periods and operate standard office equipment.
- May require occasional walking through industrial or construction areas.
- Wear Personal Protective Equipment (PPE) when required.
- Ability to work on-site at manufacturing facilities.
- 15% Domestic and International traveling required.
Benefits:
- Dental insurance
- Employee assistance program
- Health insurance
- Parental leave
- Professional development assistance
Education:
Experience:
- pharmaceutical or medical devices manufacturing expeirence: 5 years (Required)
Language:
- English and Spanish (Required)
Work Location: In person
