Pharma Senior Project Engineer – Capital Projects (On‑Site)

Alcami-5; Michigan; On-site; USD 90,000 - 130,000; Full time

Job summary

Alcami is seeking a Sr. Project Engineer to lead capital, construction, utility, process improvement and validation projects from concept to completion on-site in Michigan.

You will partner with cross-functional teams to define requirements, develop plans, manage budgets and schedules, and drive execution while ensuring quality, safety, and regulatory alignment. The role encompasses design reviews, RFP processes, vendor and contractor management, and coordinating IQ/OQ/PQ validation activities,

Qualifications

• Bachelor's degree in Engineering required.
• Minimum 4 years of engineering experience in project planning, project management, capital projects, construction, facilities, utilities, or manufacturing environments.
• Experience in pharmaceutical, biotechnology, life sciences, sterile manufacturing, or other regulated industries required.

Responsibilities

• Lead capital, construction, utility, and process improvement projects from concept through completion.
• Develop project plans including scope, requirements, resources, schedules, cost estimates, risk mitigation strategies, and communication plans.
• Monitor project progress, coordinate critical-path activities, evaluate operational impacts, and provide project status reporting to stakeholders.
• Define project specifications, equipment requirements, and technical solutions while preparing scopes of work, feasibility studies, and engineering documentation.
• Manage the full construction lifecycle, including RFP development, bid evaluations, contractor and consultant selection, design reviews, approvals, and commissioning activities.
• Lead validation activities for equipment, facilities, and utilities, including protocol development, execution, issue resolution, commissioning, and IQ/OQ/PQ documentation.
• Develop and maintain SOPs and quality documentation while supporting CAPAs, deviations, change controls, and continuous compliance initiatives.
• Ensure adherence to cGMP requirements, safety standards, customer expectations, and applicable regulatory requirements.
• Manage project budgets, CAPEX requests, expenditures, contracts, cash flow, and cost-benefit analyses to achieve financial targets.
• Partner with operations, quality, engineering, procurement, and leadership teams to gather requirements, prioritize project needs, and support strategic business goals.
• Provide day-to-day project leadership, facilitate stakeholder communication, and drive successful project execution in a fast‑paced manufacturing environment.

Skills

Project management

Budgeting

Cross-functional teams

Regulatory compliance

Communication

Problem solving

MS Office

Education

Bachelor's degree in Engineering

Tools

Microsoft Project

Excel

Job description

Alcami is seeking a Sr. Project Engineer to lead capital, construction, utility, process improvement and validation projects from concept to completion on-site in Michigan.

You will partner with cross-functional teams to define requirements, develop plans, manage budgets and schedules, and drive execution while ensuring quality, safety, and regulatory alignment. The role encompasses design reviews, RFP processes, vendor and contractor management, and coordinating IQ/OQ/PQ validation activities,