Senior Director, Engineering & Validation Excellence

Socket.dev; Morrisville (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Alcami is seeking a Sr. Director, Engineering, Validation and Maintenance to lead engineering, validation, maintenance, reliability, and manufacturing automation across the site.

You will own lifecycle management of facility, utility, and process systems, ensuring regulatory compliance and operational excellence. The role oversees capital projects, commissioning, IQ/OQ/PQ, and ongoing requalification programs, while guiding digital infrastructure and data integrity within GMP manufacturing

Qualifications

• Strategic leadership of site engineering, validation, maintenance, and automation programs.
• Accountability for regulatory compliance and operational excellence.
• Oversees lifecycle management of facility, utilities, equipment, and automation systems.

Responsibilities

• Develop and execute site engineering, validation, maintenance, metrology, reliability, and automation strategies.
• Establish KPIs and long-range plans aligned with business objectives.
• Lead and develop a high-performing technical organization with succession planning.
• Ensure compliance with cGMP, FDA, EMA, ICH, ISPE and corporate standards.
• Drive reliability, risk management, and continuous improvement across facilities and automation.

Skills

Leadership

Engineering management

Validation

Maintenance

Manufacturing automation

Regulatory compliance

Capital projects

Data integrity

Lean principles

Education

Engineering degree

Job description

Alcami is seeking a Sr. Director, Engineering, Validation and Maintenance to lead engineering, validation, maintenance, reliability, and manufacturing automation across the site.

You will own lifecycle management of facility, utility, and process systems, ensuring regulatory compliance and operational excellence. The role oversees capital projects, commissioning, IQ/OQ/PQ, and ongoing requalification programs, while guiding digital infrastructure and data integrity within GMP manufacturing