Senior Maintenance Engineer

POSITION SUMMARY

The 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 noncritical 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 ontime 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 ABILITIES

Required:

• Experienced strong seniorlevel 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 oncall support providing afterhours 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 crossfunctional 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.
• Handson fabrication experience supporting equipment reliability and process optimization.

EXPERIENCE & EDUCATION

Required:

• High School Diploma or GED.
• 7 years of experience in a highly regulated setting preferably within a cGMP biotech or pharmaceutical manufacturing environment. Handson experience in an equipmentmechanic trade (HVAC Electrical Electromechanical Plumbing or related field).
  

Preferred:

• Bachelors 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 oncall 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 $85000 -$103000: 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.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race color religion sex age national origin veteran status marital status sexual orientation gender identity disability or any other category prohibited by local state or federal law. This policy applies to all aspects of employment including recruitment placement promotion transfer demotion compensation benefits social and recreational activities and termination.