Pharma Capital Projects Lead (Construction & Validation)

Alcami Corporation; Michigan; On-site; USD 100,000 - 150,000; Full time

Job summary

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

You will ensure projects are delivered on time, within budget, and in compliance with quality, safety, cGMP, and company standards, partnering with cross‑functional teams to define requirements and drive execution. This hands‑on role includes managing budgets, RFPs, design reviews, and commissioning activities,

Qualifications

• Bachelor's degree in Engineering required.
• 4+ years in project planning/management in regulated manufacturing.
• Pharmaceutical/cGMP experience required.
• Experience with validation (IQ/OQ/PQ) preferred.

Responsibilities

• Lead capital, construction, utility, and process improvement projects from concept through completion, aligning scope, schedule, and budget with business objectives.
• Develop project plans, including scope, requirements, resources, schedules, cost estimates, and risk mitigation.
• Monitor progress, coordinate critical-path activities, and report status to stakeholders.
• Define specifications, equipment requirements, and technical solutions; prepare scopes of work and engineering documentation.
• Lead validation activities (IQ/OQ/PQ) and support CAPAs, deviations, and change controls; ensure compliance with cGMP and safety standards.

Skills

Project leadership

Cross-functional collaboration

Budget management

Regulatory compliance

Problem-solving

Education

Bachelor's degree in Engineering

Tools

Microsoft Project

Job description

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

You will ensure projects are delivered on time, within budget, and in compliance with quality, safety, cGMP, and company standards, partnering with cross‑functional teams to define requirements and drive execution. This hands‑on role includes managing budgets, RFPs, design reviews, and commissioning activities,