| Location | Spokane, WA |
| Job Type | Full-time, Employee |
| Salary | $180,000–$200,000 Per Year |
| Additional Compensation | Bonus |
Summary:
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.
Job Description:
-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.
The client will support TN1 visa for Canadian citizens and also H1B Visa Transfers if needed
Candidate Must Have:
· Bachelor's degree in a technical & related field.
· 10+ years in engineering experience in the pharmaceutical industry
· 5+ years of designing manufacturing controls systems, automation and capital project execution
· Proven leadership experience managing engineering teams and programs
· Ability to work in a fast-paced Pharma contract Manufacturing organization (CDMO)
Candidate Nice to Have:
· Degree in Engineering – Automation, Mechanical, Manufacturing, Industrial,
· Advanced degree in Engineering
· 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
· Pharmaceutical aseptic processing and equipment lifecycle Mgmt.
· Professional Engineer – PE License
o ISPE GAMP Essentials
o ISPE Good Engineering Practices
o ISPE Biopharmaceutical Essentials
o Parenteral Drug Association Aseptic Processing
o Parenteral Drug Association Annex 1
o Parenteral Drug Association Manage your Isolator for Aseptic Processing
o PMI Project Management Professional - PMP
Company Info:
Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.
This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.
Group Info: Be part of the Plant Engineering group of around 60 technical people. This role will be responsible for the technical aspects of 1 of the 4 lines
This role will report to the Engineering Director.
Note 1: The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4th line at this growing plant site.
Note 2: The primary focus will be the technical and project engineering aspects of 1 complete filling line. This person will lead and supervise up to 3 Engineers.
Note 3:Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.