Director, Engineering & Maintenance

Curia • Albuquerque, NM

8h • Onsite

About The Position

The Director of Engineering and Maintenance provides strategic leadership for all engineering, facilities, utilities, and maintenance functions within a sterile pharmaceutical manufacturing operation. This role is accountable for ensuring facility and equipment reliability, regulatory compliance, capital project execution, and continuous improvement initiatives that support aseptic manufacturing operations.

The Director serves as the site leader for engineering strategy, asset lifecycle management, utilities reliability (e.g., WFI, clean steam, HVAC, compressed gases), and facilities infrastructure. This individual ensures compliance with cGMP, FDA, OSHA, and other applicable regulatory requirements while driving operational excellence, cost control, and long-term site readiness.

The role is a key member of site leadership and serves as the primary engineering representative during regulatory inspections and customer audits.

Requirements

• Master’s degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, or a related engineering discipline with a minimum of 10 years of progressive engineering experience in pharmaceutical, biologics, or other highly regulated manufacturing environments and a minimum of 5 years of leadership experience managing engineering, maintenance, or technical teams, preferred.
• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, or a related engineering discipline with a minimum of 8 years of progressive engineering experience in pharmaceutical, biologics, or other highly regulated manufacturing environments and a minimum of 5 years of leadership experience managing engineering, maintenance, or technical teams.
• High school diploma with relevant military engineering, facilities, or technical leadership experience in regulated, mission-critical environments with a minimum of 14 years of progressive engineering experience in pharmaceutical, biologics, or other highly regulated manufacturing environments and a minimum of 5 years of leadership experience managing engineering, maintenance, or technical teams.
• Knowledge and understanding of sterile manufacturing risks and contamination control
• Minimum 5+ years of direct experience supporting aseptic/sterile processing environments.
• Strong working knowledge of: Cleanroom systems and classified environments, WFI, clean steam, HVAC, and critical utilities, Equipment qualification and validation, CMMS systems and reliability-centered maintenance, cGMP and FDA regulatory expectations
• Ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations.
• Strong written and verbal communication skills.
• Effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.
• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages.
• Strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions.
• Adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
• Demonstrates strategic thinking with strong business acumen
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail
• Ability to lead through change and drive continuous improvement
• High level of integrity, accountability, and regulatory mindset
• Experience with CMMS/CCMS platforms and maintenance management systems
• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook)
• Familiarity with manufacturing systems and automation platforms
• Strong data analysis capability to drive performance improvements
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• May be required to obtain and maintain gowning certification
• May be required to obtain and maintain media qualification
• May be required to wear a respirator

Nice To Haves

• Minimum of 5 years of leadership experience managing engineering, maintenance, or technical teams, preferred.

Responsibilities

• Develop and execute the site engineering strategy aligned with business and manufacturing objectives.
• Provide oversight of facilities, utilities, process equipment, and infrastructure supporting aseptic processing and sterile manufacturing.
• Ensure robust asset lifecycle management including design, specification, installation, qualification (IQ/OQ/PQ), maintenance, and decommissioning.
• Lead reliability engineering initiatives to improve uptime and system performance.
• Ensure full compliance with cGMP, FDA, OSHA, EPA, and other applicable regulations.
• Maintain inspection readiness at all times for FDA and other regulatory agencies.
• Serve as engineering lead during regulatory inspections and audit responses.
• Ensure engineering documentation, change control, deviations, CAPAs, and validation activities meet regulatory expectations.
• Oversee preventive, predictive, and corrective maintenance programs.
• Drive implementation and optimization of CMMS and maintenance systems (downtime tracking, PM optimization, spare parts management).
• Establish and monitor KPIs related to equipment reliability, maintenance effectiveness, and compliance metrics.
• Lead root cause investigations for critical equipment failures.
• Develop and manage the annual operating and capital budgets.
• Lead capital project planning and execution, ensuring projects are delivered safely, on time, within scope, and within budget.
• Provide technical and financial justification for capital expenditures.
• Manage contractors, vendors, and engineering service providers.
• Partner with EHS to ensure safe design and operation of facilities and utilities.
• Champion a proactive safety culture across engineering and maintenance teams.
• Ensure compliance with OSHA and environmental regulations.
• Build, develop, and retain a high-performing engineering and maintenance team.
• Provide coaching, mentorship, and succession planning.
• Establish clear performance expectations aligned with site objectives.
• Optimize organizational structure and resource allocation to support business needs.
• Partner closely with Operations, Quality, Validation, Supply Chain, and Technical Operations to support production goals.
• Support new product introductions, scale-ups, and technology transfers.
• Participate in site leadership planning and long-term capacity strategy.

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Director