Director of Engineering, Validation & Maintenance Excellence

RiseMe; Morrisville (NC); On-site; USD 180,000 - 250,000; Full time

Job summary

Alcami is seeking a Director, Engineering, Validation and Maintenance to lead strategy and execution of engineering, validation, maintenance, reliability, and manufacturing automation programs across the site, ensuring compliance, asset uptime, and business continuity.

You will oversee capital projects, qualification activities (IQ/OQ/PQ), metrology, and automation systems, partner with QA and regulatory bodies, and develop talent while driving safety, quality, and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering, Chemical, Mechanical, Biochemical, or equivalent.
• 10+ years of related experience.
• 6+ years of people leadership experience.
• Prior pharmaceutical experience; CDMO experience preferred.

Responsibilities

• Develop and implement site engineering, validation, maintenance, metrology, reliability, and automation strategies.
• Establish departmental goals, KPIs, and long‑range strategic plans.
• Build, develop, and retain a high‑performing technical organization.
• Foster a culture of safety, quality, accountability, innovation, and continuous improvement.
• Represent the department on site leadership teams, governance forums, client meetings, audits, inspections, and cross‑functional initiatives.
• Develop and manage departmental operating budgets and long‑range capital investment plans.

Education

Bachelor’s degree in Engineering, Chemical, Mechanical, Biochemical, or equivalent

Job description

Alcami is seeking a Director, Engineering, Validation and Maintenance to lead strategy and execution of engineering, validation, maintenance, reliability, and manufacturing automation programs across the site, ensuring compliance, asset uptime, and business continuity.

You will oversee capital projects, qualification activities (IQ/OQ/PQ), metrology, and automation systems, partner with QA and regulatory bodies, and develop talent while driving safety, quality, and continuous improvement.