Associate Director of Engineering

About the role

Homeland has partnered with a leading pharmaceutical contract development and manufacturing organization specializing in the development and production of sterile injectable medications to identify an experienced Associate Director of Engineering. This role provides technical and operational leadership for the design, installation, qualification, and continuous improvement of advanced aseptic filling equipment used to manufacture liquid and lyophilized pharmaceutical products. The Associate Director of Engineering will lead engineering professionals responsible for complex equipment projects, regulatory compliance, and operational excellence within a sterile pharmaceutical manufacturing environment. The ideal candidate brings extensive pharmaceutical engineering experience, in-depth knowledge of aseptic processing equipment, and a proven ability to lead engineering teams and capital equipment projects from initial design through commissioning and qualification. This is an opportunity for an Associate Director of Engineering to make a meaningful impact on manufacturing capabilities, equipment reliability, and the delivery of high-quality pharmaceutical products.

This is an opportunity to apply your engineering expertise and leadership skills in a highly regulated pharmaceutical manufacturing environment while contributing to equipment innovation, operational excellence, and the production of high-quality pharmaceutical products.

Responsibilities

Engineering Project Leadership

• Lead end-to-end projects involving aseptic filling systems, isolators, lyophilizers, and component preparation equipment
• Oversee conceptual design, procurement, installation, commissioning, and qualification of pharmaceutical manufacturing equipment
• Manage project schedules, budgets, resources, and deliverables to ensure timely execution and regulatory compliance

Equipment Design and Technical Specifications

• Develop equipment specifications for filling lines, isolators, lyophilizers, component preparation systems, product and diluent vessels, and associated SCADA components
• Collaborate with Manufacturing, Quality, and Validation teams to ensure equipment meets operational and regulatory requirements
• Provide technical expertise in equipment selection, implementation, and optimization

Installation, Commissioning, and Qualification

• Oversee equipment installation, integration, and commissioning within existing manufacturing facilities
• Lead installation, operational, and performance qualification (IQ/OQ/PQ) activities in accordance with approved protocols and regulatory standards
• Drive improvements in equipment reliability, performance, and operational efficiency

Regulatory Compliance and Documentation

• Ensure engineering activities comply with applicable FDA, EMA, ICH, and industry guidelines
• Prepare and review user requirement specifications (URS), factory and site acceptance testing (FAT/SAT) documentation, and equipment qualification protocols
• Lead equipment-related deviation investigations, corrective and preventive actions (CAPA), and remediation efforts while supporting audits and regulatory inspections

Engineering Team Leadership

• Lead, coach, and mentor exempt and non-exempt engineering and technical personnel
• Foster a culture of safety, quality, accountability, collaboration, and continuous improvement
• Support employee development, technical problem-solving, and effective project execution

Vendor and Contractor Management

• Evaluate, qualify, select, and manage equipment suppliers and contractors
• Coordinate vendor deliverables to ensure alignment with technical specifications, quality standards, project schedules, and budgets
• Participate in contract negotiations and monitor supplier performance

Requirements

• 12+ years of pharmaceutical engineering experience, including at least 3 years working on aseptic filling equipment projects
• 5+ years managing technical or engineering personnel
• Proven success leading equipment design, installation, commissioning, and qualification projects in cGMP environments
• Strong understanding of aseptic manufacturing, isolator technology, and lyophilization; ability to manage complex cross-functional projects
• Knowledge of sterile manufacturing operations, equipment qualification, validation, deviations, and CAPA processes
• Understanding of FDA, EMA, ICH, ISPE, and applicable pharmaceutical regulatory guidance
• Ability to interpret CAD drawings, P&IDs, instrumentation and controls documents, control logic, and hardware architecture
• Project management, budgeting, resource planning, and proficiency in Microsoft Office applications and SAP
• Experience with automated filling lines and robotics, preferred
• Knowledge of cleanroom design and environmental monitoring systems, preferred
• Ability to manage multiple complex projects in a fast-paced manufacturing environment, preferred
• ISPE GAMP Essentials, Good Engineering Practices, and Biopharmaceutical Essentials
• Parenteral Drug Association (PDA) training in Aseptic Processing, EU GMP Annex 1, and Isolator Management, preferred
• Project Management Professional (PMP) or ISA Certified Automation Professional (CAP), preferred
• Effective leadership, mentoring, communication, and conflict management skills, preferred
• Ability to influence decisions and collaborate across departments, preferred
• Proactive, self-directed approach to planning and executing highly technical work, preferred
• Strong analytical, organizational, and problem-solving capabilities, preferred

Schedule

Full-time, onsite position based in Spokane, WA, Monday–Friday, 8:00 AM to 4:30 PM.

Benefits

Annual salary of $149,000–$190,000, opportunities for career growth and annual raises, and comprehensive benefits starting on day one, including medical, dental, and vision coverage, FSA and HSA options, life and disability insurance, and an Employee Assistance Program.