Pharmatek Consulting Inc.
CQV Project/Program Manager
Pharmatek Consulting Inc., Mount Vernon, Indiana, United States, 47620
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.
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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.
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