Sr. Director, Engineering, Validation & Maintenance

Alcami Corporation • Morrisville, NC

4d • Onsite

About The Position

The Sr. Director, Engineering, Validation and Maintenance is responsible for the strategic leadership, development, and execution of engineering, validation, maintenance, reliability, and manufacturing automation programs that support current operations and future growth of the site. This role provides end-to-end lifecycle ownership of facility, utility, manufacturing, laboratory, and automation systems, ensuring regulatory compliance, operational excellence, asset reliability, and business continuity.
The Sr. Director leads all aspects of engineering, including capital project planning and execution, facility and utility design, equipment procurement, installation, commissioning, and lifecycle management. The role oversees validation activities, including commissioning, qualification (IQ/OQ/PQ), computerized system validation, and ongoing requalification programs. Additionally, the position is responsible for site maintenance, metrology, and reliability engineering programs focused on maximizing equipment uptime, optimizing asset performance, reducing operational risk, and implementing predictive and reliability-centered maintenance strategies.
The role also provides leadership for manufacturing automation and digital infrastructure, including process control systems, SCADA, PLCs, manufacturing data systems, historian platforms, and computerized systems that support GMP manufacturing operations. The Sr. Director drives automation and digital transformation initiatives that improve process robustness, data integrity, operational efficiency, and manufacturing scalability.
As a key member of the site leadership team, the Sr. Director develops and executes long-range capital and infrastructure strategies while ensuring facility, utility, contamination control, and automation systems remain aligned with current regulatory expectations and business objectives. The position serves as a technical leader during client interactions, regulatory inspections, and corporate initiatives, while building organizational capability through talent development, succession planning, and continuous improvement.
This role fosters a culture of safety, quality, compliance, reliability, innovation, and operational excellence by leveraging modern engineering practices, Lean principles, risk-based decision-making, and cross-functional collaboration to support the successful delivery of sterile pharmaceutical manufacturing operations.

Requirements

• Bachelor’s degree in Engineering, Chemical, Mechanical, Biochemical, or equivalent required.
• 15+ years of related experience required.
• 6+ years of people leadership experience required.
• Prior pharmaceutical experience required; prior CDMO experience preferred.
• Expert knowledge of pharmaceutical engineering, facilities, utilities, maintenance, reliability engineering, validation lifecycle management, and manufacturing automation within GMP-regulated environments.
• Advanced knowledge of sterile manufacturing operations, aseptic processing systems, cleanroom operations, and critical utility systems.
• Extensive knowledge of cGMP regulations, FDA, EU GMP Annex 1, ICH, ISPE, ASTM, and industry best practices applicable to pharmaceutical manufacturing facilities.
• Strong understanding of equipment lifecycle management, asset reliability, risk management, and continuous improvement methodologies.
• Advanced knowledge of commissioning, qualification, validation, and computerized system validation (CSV) principles, including FAT, SAT, IQ, OQ, PQ, and ongoing lifecycle management.
• Strong understanding of clean utilities and critical infrastructure systems including HVAC, purified water, WFI, clean steam, compressed gases, and environmental monitoring systems.
• Working knowledge of quality systems including deviations, CAPA, change control, risk assessments, and audit management.
• Knowledge of process control systems, PLCs, SCADA, DCS, HMIs, manufacturing execution systems (MES), historian platforms, and industrial automation technologies.
• Knowledge of data integrity, cybersecurity principles, and validation requirements associated with GMP computerized systems.
• Thorough understanding of metrology, calibration, and measurement system management principles.
• Demonstrated ability to develop and execute strategic plans that support site growth, operational excellence, and long-term business objectives.
• Strong leadership capability with proven success building, leading, and developing high-performing technical organizations.
• Excellent business acumen with the ability to align engineering investments, capital expenditures, and operational priorities with business strategy.
• Proven ability to manage complex capital projects and multi-disciplinary technical programs from concept through implementation.
• Ability to identify organizational capability gaps and implement talent development and succession planning strategies.
• Strong change management skills with experience leading organizational transformation and continuous improvement initiatives.
• Experience utilizing equipment reliability and maintenance performance metrics including equipment uptime, schedule compliance, and asset utilization.
• Strong analytical and root cause investigation skills utilizing structured problem-solving methodologies.
• Proven experience implementing operational excellence, Lean manufacturing, and continuous improvement programs that improve performance, reliability, compliance, and cost effectiveness.
• Ability to leverage data and performance metrics to drive informed business decisions and performance improvements.
• Extensive experience supporting regulatory inspections, client audits, and internal quality audits within GMP manufacturing environments.
• Strong understanding of global pharmaceutical regulations and quality expectations for sterile drug product manufacturing.
• Experience developing, executing, and maintaining compliant engineering, maintenance, automation, validation, and calibration programs.
• Ability to interpret and apply regulatory guidance, industry standards, and company procedures to ensure inspection readiness and compliance.
• Exceptional verbal, written, presentation, and interpersonal communication skills.
• Proven ability to effectively interface with clients, regulatory agencies, auditors, executive leadership, and cross-functional teams.
• Ability to communicate complex technical concepts to diverse audiences at all organizational levels.
• Experience leading technical discussions, due diligence activities, customer audits, and strategic client engagements.
• Demonstrates the highest level of integrity, professionalism, accountability, and ethical conduct.
• Results-oriented leader with a strong sense of urgency and commitment to execution.
• Promotes a culture of safety, compliance, quality, innovation, and continuous improvement.
• Collaborative leader who builds strong partnerships across functions, sites, and external stakeholders.
• Highly motivated self-starter with strong critical thinking and problem-solving capabilities.
• Displays intellectual curiosity and embraces innovation to improve business performance and organizational effectiveness.
• Treats colleagues, customers, and business partners with professionalism, respect, and inclusiveness.
• Maintains a strong customer-focused mindset while balancing compliance, quality, operational, and business objectives.

Nice To Haves

• Experience supporting sterile fill/finish, aseptic manufacturing, biologics, or injectable pharmaceutical operations.
• Experience within a CDMO environment supporting multiple clients, products, and technologies.
• Experience leading facility expansions, new facility startups, technology transfers, or major capital investment programs.
• Experience managing global or multi-site engineering, validation, reliability, maintenance, or automation initiatives.
• Experience implementing digital manufacturing, Industry 4.0, asset management, reliability, or automation transformation programs.

Responsibilities

• Develop, implement, and continuously improve site engineering, validation, maintenance, metrology, reliability, and automation strategies that support current operations, future growth, compliance, and operational excellence objectives.
• Establish departmental goals, key performance indicators (KPIs), and long-range strategic plans aligned with business objectives and network standards.
• Build, develop, and retain a high-performing technical organization through effective leadership, coaching, mentoring, succession planning, and talent development.
• Foster a culture of safety, quality, accountability, innovation, operational excellence, 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.
• Provide strategic and technical leadership for facility, utility, manufacturing, laboratory, and process support systems throughout the asset lifecycle.
• Oversee engineering activities including conceptual design, scope development, budgeting, procurement, construction management, installation, commissioning, startup, and lifecycle management.
• Ensure equipment, facility, utility, and automation systems are designed, maintained, and operated in accordance with cGMP, regulatory requirements, corporate standards, and industry best practices.
• Serve as the site subject matter expert (SME) for facility infrastructure, clean utilities, process equipment, contamination control systems, and critical GMP support systems.
• Support sterile manufacturing operations through effective management of engineering resources and technical problem-solving.
• Oversee facility, utility, equipment, process, and computerized system validation programs.
• Ensure execution of commissioning, qualification, and validation activities including FAT, SAT, IQ, OQ, PQ, requalification, and periodic review programs.
• Partner with Quality to maintain compliant validation systems aligned with cGMP, FDA, EMA, ICH, ISPE, and corporate requirements.
• Support internal audits, customer audits, and regulatory inspections while ensuring timely completion of commitments and corrective actions.
• Drive continuous improvement of validation lifecycle management and risk-based qualification practices.
• Establish and maintain a Reliability Engineering program focused on maximizing equipment availability, minimizing downtime, and reducing lifecycle costs.
• Develop and monitor key reliability metrics including equipment uptime, schedule compliance, and asset utilization.
• Assist with root cause investigations and corrective actions related to equipment failures, recurring deviations, and operational losses.
• Drive asset lifecycle management strategies to optimize performance, reliability, maintainability, and regulatory compliance.
• Provide leadership and oversight for campus maintenance programs, including preventive, predictive, corrective, and emergency maintenance activities.
• Ensure effective execution of work management processes, planning and scheduling systems, spare parts management, and CMMS utilization.
• Lead facility programs including security systems, contractor management, building maintenance, grounds management, housekeeping oversight, pest control, and infrastructure sustainability.
• Ensure facility and utility systems are maintained in a state of inspection readiness and operational reliability.
• Lead site manufacturing automation strategy, governance, and execution to support operational excellence and digital transformation initiatives.
• Provide oversight for automation systems including PLCs, SCADA, DCS, HMI, historian platforms, manufacturing data systems, and related computerized systems.
• Partner with Operations, Quality, IT, and MS&T to implement automation solutions that improve process robustness, data integrity, efficiency, and scalability.
• Drive modernization of manufacturing systems through digital technologies, advanced analytics, system integration, and automation lifecycle management.
• Ensure automation systems comply with applicable regulatory requirements, data integrity standards, cybersecurity expectations, and validation requirements.
• Lead the site metrology function, ensuring effective calibration, maintenance, repair, and lifecycle management of critical instruments and measurement systems.
• Maintain compliant calibration systems that support manufacturing, laboratory, facility, and utility operations.
• Drive continuous improvement initiatives that enhance measurement accuracy, reliability, and operational efficiency.
• Lead engineering aspects of business continuity planning, disaster recovery preparedness, infrastructure redundancy, and risk mitigation strategies.
• Support and advance site sustainability and ESG initiatives through energy management, utility optimization, refrigerant stewardship, and environmental improvement projects.
• Assess operational and technical risks and implement mitigation strategies to ensure business continuity and regulatory compliance.
• Directly lead engineering, validation, maintenance, reliability, metrology, and automation leaders and their associated teams.
• Establish clear performance expectations and accountability measures.
• Conduct hiring, performance management, coaching, development, succession planning, and employee engagement activities.
• Ensure all personnel maintain required technical competencies, training qualifications, and compliance requirements.
• Promote a highly engaged, inclusive, and performance-driven culture focused on safety, quality, service, and operational excellence.
• Independently make strategic and operational decisions impacting site infrastructure, compliance, reliability, and manufacturing capability.
• Utilize data-driven decision making, Lean principles, and continuous improvement methodologies to enhance performance.
• Other duties as assigned.

Benefits

• Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

What This Job Offers

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