Job Description:

The Associate Director, Controls Engineering provides is a highly technical individual providing

strategic leadership and operational accountability over the company's entire automation philosophy

and program development. This includes defining the composition of the Operational Technology (OT)

network, developing operational and maintenance procedures and defining hardware and software

specifications for all manufacturing and facilities equipment. This role ensures that controls and

computer based systems across the organization are designed, implemented, and maintained in

compliance with regulatory requirements and aligned with business objectives that include efficiency

to support scaling operations. This position leads controls engineering activities supporting

manufacturing, facilities, maintenance, and capital projects, ensuring adherence to Good Engineering

Practices (GEP) and current Good Manufacturing Practices (cGMP), while driving innovation, process

improvement, and operational excellence. This role will define strategies to maintain compliant

systems in accordance with all applicable regulations and industry guidance including CFR 21 part 11,

Annex 11, EU GMP, PIC/S PI-041 and GAMP 5 covering system integrity, data integrity, audit trail

reviews and user role development and access management. This role will work hand in hand with the

Validation and Quality Assurance teams to achieve a robust end to end program.

-Leadership & Strategy • Provide leadership and technical oversight for the Controls Engineering function, building a culture of accountability and excellence in delivery and customer service. Establish a talent development and succession plan. • Develop and execute long-term controls strategy aligned with corporate growth, compliance, and digital transformation initiatives. • Develop efficient tools to effectively evaluate areas of opportunity, and deliver short term objectives to improve robust and consistent operations

-Controls Engineering & OT Systems • Provide expert oversight of OT system definition, including PLCs, HMIs, SCADA, historians, and networked control systems. • Establish viable solutions to accommodate off line recipe management, retrieval and archival, data historian, and streamlined audit trail functionally and review. • Ensure reliability, security, and lifecycle management of automation and controls systems across the site. • Equip team to effectively diagnose and resolve complex control system issues, I a timely and complaint manner, providing technical guidance when needed.

-Capital Projects & Execution • Manage engineering resources and external partners (A&E firms, vendors, contractors) to support project delivery. • Oversee and execute controls-related capital and expense projects, including facilities and equipment expansions, compliance upgrades, and process improvements. • Ensure projects are delivered on time, within budget, and aligned with JHS project management standards.

-Compliance & Quality • Ensure all controls systems and engineering activities comply with local, state, federal, and international regulatory requirements (FDA, cGMP, EU and Annexes). • Maintain systems and documentation in alignment with GAMP5, data integrity standards, and quality expectations.

-Operational Support & Continuous Improvement • Support manufacturing and maintenance teams with technical expertise to drive uptime, efficiency, and process optimization driving OEE metrics. • Enable comprehensive access and reporting to critical performance data. • Lead initiatives for cost reduction, automation enhancements, and process improvements. • Support investigations, deviations, and root cause analysis related to control systems with a goal of deviation reduction.

-Stakeholder & Communication • Communicate project status, risks, and priorities to senior leadership. • Partner cross-functionally with QA, Manufacturing, Validation, MS&T, and external stakeholders. • Support client audits, regulatory inspections, and technical visits.

Required:

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Computer Science, or related discipline)
• 10+ years of engineering experience in a regulated manufacturing environment (pharmaceutical preferred)
• 5+ years experience designing, managing manufacturing controls systems, automation, and capital project execution
• Proven leadership experience managing engineering teams and programs

Preferred:

• Degree in automation field preferred.
• Applicable ISPE certifications, ISA Certified Automation Professional, Certification in Automation and Data Analytics or similar.
• Allen-Bradley PLCs, PanelView HMIs, Servo Drives
• Rockwell/FactoryTalk, Wonderware, Historian systems
• GAMP5, Data Integrity, validation lifecycle
• TCP/IP networking and industrial control systems
• AutoCAD (preferred)

Working Environment:

• Prolonged sitting/standing •
• Ability to navigate manufacturing environment
• Work in classified/aseptic areas
• Exposure to facility and equipment conditions (e.g., confined spaces, allergens)

Location: Spokane, WA - On Site, Full- -Time

Shift: Weekday Days

Compensation & Benefits That Start on Day One - Because Your Well Being Matters

Hiring Wage: $141,900 - $227,000 salary + 15% annual bonus, with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting on your first day, you receive:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program