CQV Project/Program Manager

Pharmatek Consulting Inc.; City of Mount Vernon (NY); On-site; USD 120,000 - 170,000; Full time

Job summary

Pharmatek Consulting Inc. is seeking a Senior Capital Projects Manager to lead full lifecycle capital initiatives for a GMP manufacturing site. You will coordinate with manufacturing, quality, and validation teams to ensure on-time delivery and regulatory compliance.

Ideal candidates have 7–10 years in pharma manufacturing, strong budgeting skills, and robust leadership abilities to drive cross-functional collaboration and vendor management.

Qualifications

• 7–10 years of experience in pharmaceutical manufacturing with focus on Oral Solid Dosage and packaging.
• Proven track record in capital project management across multiple projects.

Responsibilities

• Capital Project Management: lead full lifecycle from planning to closeout.
• Technical Leadership: oversee facilities, GMP processes, automation upgrades, QC equipment.
• Budget & Financial Oversight: develop budgets, monitor spend, report variances.
• Documentation & Phase Deliverables: ensure documentation and phase gates compliance.
• Cross-Functional Collaboration: partner with Manufacturing, Quality, Validation.
• Vendor & Contractor Management: manage external firms and equipment vendors.

Skills

Capital project management

Technical leadership

Budgeting & forecasting

Cross-functional collaboration

Vendor management

GMP knowledge

Education

Bachelor’s degree in Engineering

Tools

Microsoft Project

Job description

Mount Vernon, United States | Posted on 12/06/2025

• Industry Pharma/Biotech/Clinical Research
• Job Type Full time
• Work Experience 5+ years
• State/Province Indiana
• Country United States

Job Description

KEY RESPONSIBILITIES

• Capital Project Management: Lead and manage full lifecycle of capital projects, including planning, budgeting, execution, and closeout, ensuring alignment with site and corporate goals.
• Technical Leadership: Oversee engineering activities for projects including, but not limited to: Facilities/Utilities supporting Oral Solid Dosage Manufacturing and Packaging, GMP processes, Automation upgrades, and QC Lab equipment.
• Budget & Financial Oversight: Develop and maintain accurate project budgets and forecasts; monitor project spend, track variances, and ensure financial accountability for capital expenditures.
• Documentation & Phase Deliverables: Ensure adherence to established project documentation, phase gates, and change management processes for technical and operational projects.
• Cross-Functional Collaboration: Partner with Manufacturing, Quality, Validation, and other cross-functional stakeholders to deliver integrated project outcomes and support site readiness for commercial and clinical operations.
• Vendor & Contractor Management: Manage external engineering firms, equipment vendors, and contractors to ensure adherence to project scope, quality, safety, and schedule requirements

Requirements

Experience:

• Minimum 7–10 years of experience in pharmaceutical manufacturing with a focus on Oral Solid Dosage Manufacturing and Packaging, GMP processes, Automation upgrades, and QC Lab equipment.
• Proven track record in capital project management, managing multiple projects at once.

Technical Expertise:

• Strong understanding of Facilities/Utilities supporting Oral Solid Dosage Manufacturing and Packaging, GMP processes, Automation upgrades, and QC Lab equipment.
• Knowledge of pharmaceutical packaging, modern controls and safety devices, tablet inspection systems, SCADA/PAS-X integrations, and equipment validation.
• Familiarity with process utilities and equipment qualification protocols (IQ/OQ/PQ).
• Highly skilled utilizing Microsoft Project for schedule/project plan development.
• Skilled in budgeting, forecasting, and cost control within complex, regulated environments.

Soft Skills:

• Strong leadership and communication skills, with the ability to influence cross-functional teams.
• Highly organized, detail-oriented, and capable of managing multiple priorities in a dynamic environment.

Other:

• Willingness to work onsite at a GMP manufacturing facility

Education:

• Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related discipline). Advanced degree preferred.