Sr. Maintenance Engineer (Onsite)

POSITION SUMMARY

The Sr. Maintenance Engineer is a highly skilled selfdirected technical contributor responsible for the installation troubleshooting and preventive/corrective maintenance of site-wide equipment supporting operations across cGMP manufacturing nonGMP facilities and laboratory environments. This onsite position reports to the Maintenance Supervisor within the Engineering department at the Northpointe facility in Lynnwood WAa commercialscale cGMP manufacturing site producing Leukine (sargramostim) a therapeutic glycoprotein. Active participation in rotational oncall programs providing afterhours technical response to maintenance and facility emergencies to ensure operational continuity is required.

PRIMARY RESPONSIBILITIES

• Collaborates across functions and with customer groups throughout the Company to deliver maintenance project and continuous improvement support across the full asset lifecycle ensuring responsive service and strong customer satisfaction.
• Adheres to cGMP standards and procedures by thoroughly documenting equipment and system operations and maintenance within the cGMP production environment utilizing the Asset Management System (AMS) and other relevant data repositories.
• Applies advanced technical expertise to the maintenance operation and optimization of critical and noncritical utility systemsincluding HVAC electronic controls refrigeration emergency power generation and electrical distribution clean compressed air and highpressure medical gas systems purified water WFI water industrial wastewater treatment and plant and clean steam generation and distributionensuring reliability and compliance within cGMP environments.
• Executes preventive and corrective maintenance on cGMP manufacturing process equipmentincluding pressurerated vessels agitators/mixers with variablespeed drives chromatography skids and column assemblies steam sterilizers (autoclaves) automated glasswash systems and sanitarydesign centrifugal and diaphragm pumps and valvesensuring compliance with cleanroom operational standards and aseptic equipment design requirements.
• Coordinates and applies technical expertise to the scheduling and execution of system inspections testing maintenance and contractorperformed services ensuring regulatory compliance thorough documentation operational continuity and on time completion of all assigned work.
• Understand and consistently apply maintenance and repair practices that uphold the qualified and validated status of cGMP equipment ensuring all work is performed in strict accordance with established procedures changecontrol requirements and regulatory expectations.
• Maintains compliance with all applicable requirements including internal Standard Operating Procedures (SOPs) cGMP regulations Health and Safety standards WISHA/OSHA guidelines regulatory obligations company policies and employmentrelated laws and statutes.
• Demonstrates a proactive approach to identifying operational inefficiencies proposing technical enhancements and implementing improvements that strengthen equipment reliability system performance and overall operational effectiveness.
• Reviews and interprets drawings layouts wiring diagrams and technical specifications to support effective planning and execution of maintenance and repair activities.
• Performs periodic gowning and degowning procedures in accordance with Cleanroom Standard Operating Practices and established PPE requirements as needed.
• Rotates daily facility inspection and logentry responsibilities with team members to ensure consistent monitoring and documentation of site conditions.
• Completes all required Safety Quality and Compliance training within established deadlines.

KNOWLEDGE SKILLS ABILITIES

Required:

• Advanced troubleshooting capabilities applying structured diagnostic methodologies to resolve complex equipment utility and system issues.
• Extensive preventive and corrective maintenance experience across industrial process and laboratory equipment with the ability to evaluate failure modes and recommend improvements.
• Comprehensive understanding of safety programs and regulatory requirements including expertlevel application of LOTO (Lockout/Tagout) and other safetycritical procedures.
• Proficient use of Asset Management Systems (e.g. Maximo BMRAM) including work order execution asset history review and data accuracy practices.
• Experience with creating revising and maintaining Standard Operating Procedures (SOPs) and/or Job plans applying strong technical knowledge and compliance awareness to ensure procedures are clear accurate cGMPaligned and reflective of current operational practices.
• Strong digital literacy including advanced proficiency in Microsoft Word Excel and Outlook with the ability to quickly adopt and utilize additional jobspecific applications.
• Ability to work effectively both independently and within crossfunctional technical teams demonstrating initiative accountability and strong collaboration skills.
• Exceptional interpersonal and professional skills including a bias for action openness to giving and receiving constructive feedback adaptability and the ability to operate effectively within diverse teams and dynamic environments.
• Strong English communication skills written and verbal with the capability to clearly articulate technical issues provide recommendations and actively engage in crossfunctional meetings and discussions.
• Demonstrated experience leading or contributing to root cause analysis (RCA) CAPAs and change control processes.

Preferred:

• Expertise in cleanroom HVAC system operation with the ability to assess performance diagnose complex faults and optimize system efficiency.
• Heat transfer and fluid flow fundamentals including application to process equipment utility distribution and system troubleshooting.
• Pump and valve technologies including selection operation performance characteristics and failuremode analysis.
• Expertise in water system technologies (e.g. RO/DI distillation & WFI) including operation monitoring and maintenance in regulated environments.
• Plant and Clean Steam generation and distribution systems with a strong understanding of steam principles condensate management and system reliability considerations.
• Mechanical and electrical troubleshooting leveraging a systematic approach to diagnose and resolve issues across integrated utility and process systems.
• Familiarity with PLC control and VFD operation including the ability to interpret control logic evaluate automation behaviors and troubleshoot controlrelated system issues.
• Industry standards and technical guidance (ISPE ASME IEEE ISO or equivalent) with the ability to apply relevant requirements to maintenance practices equipment operation and system integrity.
• Demonstrated fabrication experience including the ability to design build and modify custom components to support equipment reliability and process optimization.

EXPERIENCE & EDUCATION

Required:

• Associate degree or completion of a formal technical/trade program in a relevant discipline.
• 10 years of handson experience in an equipmentmechanic trade (HVAC Electrical Electromechanical Plumbing or related field).
• 5 years of experience in a highly regulated setting preferably within a cGMP biotech or pharmaceutical manufacturing environment.

Preferred:

• Bachelors degree in engineering or related technical discipline (Mechanical Electrical Chemical or Industrial Engineering).
• Certification or training in Lean Six Sigma or continuous improvement methodologies.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $90000 -$105000: 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 and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes pre-IPO options annual cash bonuses 401k matching free parking or Seattle-area ORCA pass tuition assistance plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy wellness participation programs and a generous vacation sick and holiday paid time off program in addition to a paid shutdown between the Christmas and New Years holidays.

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.