Associate Director of Engineering Professional Services
Spokane, Washington Direct Hire Oct 22, 2026
Job Summary 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.
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
Additional Information This is a full-time, onsite position based in Spokane, WA, with a Monday–Friday schedule from 8:00 AM to 4:30 PM.
Benefits This role offers an 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.
Summary 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.
EEO Notice Homeland LLC is an Equal Opportunity Employer. Homeland LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Homeland LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. Reasonable accommodation is available for qualified individuals with disabilities, upon request.