POSITION SUMMARYThe Senior Maintenance Engineer serves as a key technical resource, responsible for the installation, maintenance, troubleshooting, and repair of critical facility and production equipment supporting cGMP manufacturing, laboratory environments, and non-GMP operations. This role requires a proactive, self-motivated professional with strong HVAC systems expertise and a demonstrated ability to independently resolve complex technical issues. The position is based onsite at the Northpointe facility in Lynnwood, WA, and reports directly to the Maintenance Manager within the Engineering Department. Northpointe is a commercial-scale cGMP manufacturing facility producing Leukine® (sargramostim), a therapeutic glycoprotein.
PRIMARY RESPONSIBILITIES- Maintains, operates, and optimizes critical and non-critical utility systems (HVAC, controls, refrigeration, emergency power, electrical distribution, compressed air, medical gases, purified/WFI water, wastewater, and steam systems) in cGMP environments.
- Collaborates across functions and with customers to support maintenance, projects, and continuous improvement across asset lifecycle.
- Ensures cGMP compliance through accurate documentation of equipment operations and maintenance using AMS and related systems.
- Plans, schedules, and oversees inspections, testing, maintenance, and contractor work to ensure compliance, documentation, and on-time completion.
- Performs all maintenance and repairs in accordance with cGMP procedures, validation requirements, change control, and regulatory expectations.
- Complies with SOPs, cGMP regulations, safety standards, OSHA/WISHA requirements, company policies, and applicable laws.
- Proactively identifies inefficiencies and implements improvements to enhance reliability, performance, and operational effectiveness.
- Interprets drawings, schematics, and technical specifications to support maintenance and repair activities.
- Executes preventive and corrective maintenance on cGMP process equipment, including vessels, mixers, chromatography systems, autoclaves, washers, pumps, and valves, in cleanroom environments.
- Performs gowning and PPE procedures as required by cleanroom standards.
- Participates in facility inspections, log entries, and required safety, quality, and compliance training.
- Performs other assigned duties as needed.
KNOWLEDGE, SKILLS, ABILITIESRequired:- Experienced strong senior-level technical proficiency, including:
- Advanced troubleshooting skills using structured diagnostics to resolve complex equipment, utility, and system issues.
- Strong preventive and corrective maintenance experience across industrial, process, and laboratory equipment, including failure mode analysis.
- Expert knowledge of safety programs and regulatory requirements, including LOTO and other critical procedures.
- Proficient with Asset Management Systems (e.g., Maximo, BMRAM) for work orders, asset history, and data accuracy.
- Participates in rotational on-call support, providing after-hours response to maintenance and facility emergencies.
- Develops and maintains SOPs and job plans, ensuring clarity, accuracy, and cGMP compliance.
- Advanced proficiency in Microsoft Word, Excel, and Outlook; quick to adopt new applications.
- Works effectively both independently and in cross-functional teams, demonstrating accountability and initiative.
- Strong interpersonal skills, adaptability, and openness to feedback in dynamic environments.
- Clear written and verbal English communication, including technical discussion and recommendations.
- Experience supporting deviation investigations, root cause analysis (RCA), CAPA implementation, and change control activities in a cGMP-regulated environment to maintain compliance and enhance operational performance.
Preferred: - Advanced technical knowledge and practical experience in any of the following areas:
- Expertise in cleanroom HVAC operation, performance assessment, fault diagnosis, and efficiency optimization.
- Strong understanding of heat transfer and fluid flow as applied to process equipment and utility systems.
- Knowledge of pump and valve technologies, including operation, performance, and failure analysis.
- Experience with regulated water systems (RO/DI, distillation, WFI), including operation and maintenance.
- Proficiency with plant and clean steam generation and distribution systems.
- Mechanical and electrical troubleshooting across integrated utility and process systems.
- Familiarity with PLCs and VFDs, including control logic interpretation and automation troubleshooting.
- Working knowledge of industry standards (ISPE, ASME, IEEE, ISO) applied to equipment and maintenance practices.
- Hands-on fabrication experience supporting equipment reliability and process optimization.
EXPERIENCE & EDUCATIONRequired:- High School Diploma or GED.
- 7+ years of experience in a highly regulated setting, preferably within a cGMP biotech or pharmaceutical manufacturing environment. Hands-on experience in an equipment-mechanic trade (HVAC, Electrical, Electromechanical, Plumbing, or related field).
Preferred:- Bachelor's degree or Associate degree or completion of a formal technical/trade program in a relevant discipline.
- Certification or training in Lean, Six Sigma, or continuous improvement methodologies.
SPECIAL WORKING CONDITIONS:- Ability to lift, push, and pull up to 50 pounds.
- Ability to stand, walk, climb, kneel, crouch, and work in confined or elevated spaces for extended periods.
- Comfortable working in variable environments, including noisy, hot, cold, humid, mechanical, and outdoor areas.
- Able to wear required PPE, including safety gear and full cleanroom gowning.
- Ability to safely work around moving equipment, pressurized systems, electrical panels, and rotating machinery.
- Capable of reading gauges, digital displays, and performing detailed visual inspections.
- Manual dexterity to use tools, instruments, and small components.
- Ability to respond quickly to equipment emergencies.
- Willingness to work shifts, weekends, overtime, and participate in on-call rotations as needed.
- Ability to perform repetitive tasks, including valve operation, equipment access, and computer data entry.
Alternate Work Hours Detail (on call, weekend, night shift, etc.):- Onsite presence with a standard 8-hour work shift of Mon-Fri or optional shift of 10-hour shift of Mon-Thur or Tues-Fri.
- Flexibility in work hours and workdays may be needed dependent on business conditions: Ability and willingness to work on call, occasional weekends, holidays, and/or overtime as needed.
PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $85,000 -$103,000: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.
In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual Hybrid or Remote workplace program for many roles. We also offer a highly competitive compensation and benefits package, including an annual discretionary cash bonus and a 401(k) matching program. Partners in the Seattle area can take advantage of a free ORCA pass, and we also provide tuition and continuing education assistance to support ongoing professional development. Recognition for outstanding contributions and achievements is a core part of our culture.
