Katalyst CRO ยท 1 month ago
CQV Project Manager/Program Manager Consultant
Mount Vernon, IN
Contract
Onsite
Senior Level
7+ years expKatalyst Healthcares & Life Sciences is seeking a CQV Project Manager/Program Manager Consultant to lead and manage the full lifecycle of capital projects. The role involves overseeing engineering activities, managing project budgets, and ensuring alignment with corporate goals while collaborating with cross-functional stakeholders.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead and manage full lifecycle of capital projects, including planning, budgeting, execution, and closeout, ensuring alignment with site and corporate goals
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
Develop and maintain accurate project budgets and forecasts; monitor project spends, track variances, and ensure financial accountability for capital expenditures
Ensure adherence to established project documentation, phase gates, and change management processes for technical and operational projects
Partner with Manufacturing, Quality, Validation, and other cross-functional stakeholders to deliver integrated project outcomes and support site readiness for commercial and clinical operations
Manage external engineering firms, equipment vendors, and contractors to ensure adherence to project scope, quality, safety, and schedule requirements
Qualification
Required
Bachelor's degree in engineering (Mechanical, Chemical, Industrial, or related discipline)
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
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/Client-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
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
Willingness to work onsite at a GMP manufacturing facility
Preferred
Advanced degree preferred
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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