Talent.com
Sunrise Systems
Process EngineerSunrise Systems • Seattle, Washington, United States
Process Engineer

Process Engineer

Sunrise Systems • Seattle, Washington, United States
30+ days ago
Job type
  • Full-time
  • Quick Apply
Job description

Job Title: Process Engineer

Duration: 12 months on W2 Contract (Possible extension based on performance)

Location: Seattle, WA 98109

Onsite/Hybrid: Hybrid (50%+ days onsite required, days of week are flexible)

Schedule: Normal Business hours


Job Description:

Top Skills Required-

  • Proven ability to lead and drive projects within cross-functional teams, ensuring alignment and collaboration across multiple departments and organizations. Looking for a proactive and independent thinker.
  • Extensive experience with change control processes, document approvals, and the management of Standard Operating Procedures (SOPs), Work Instructions (WIs), deviations, and Corrective and Preventive Actions (CAPAs) within a quality management system.
  • Hands-on experience in the cell therapy field, particularly with CAR-T (Chimeric Antigen Receptor T-cell) products.
  • Exceptional interpersonal and communication skills, with a demonstrated ability to build strong relationships and a positive reputation with various teams and stakeholders.


Top Skills:

  • Life Cycle Management Experience
  • Experience developing and implementing process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
  • Familiarity with cell therapy processes and cGMPs
  • Experience assimilating large data sets in support of batch history sections for regulatory submissions.
  • Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.


Position Summary:

Cell Therapy Technical Operations (CTTO) is responsible for global product lifecycle strategy and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product lifecycle. The Senior Engineer will be responsible for the implementation of cell therapy manufacturing technologies, and process changes related to the life-cycle management of a commercial CAR-T Therapy. This includes establishing the strategy for process changes, coordinating technical alignment, and lead implementation at a global level. This role collaborates across all CMC functional areas and drug product manufacturing sites to ensure project advancement, rapid and best-in-class execution, and communication of challenges/opportunities. The candidate will help drive the validation, qualification, and comparability strategies.


Duties/Responsibilities:

  • Lead the commercial lifecycle plan for a cellular product, maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.
  • Develop and implement process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
  • Develop product technical strategies including manufacturing requirements, process improvement plans, and ensure successful and timely execution working across functional groups.
  • Provide technical content for significant documents such as validation activities, author content for regulatory submissions.
  • Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions.
  • Provide necessary technical analysis to support impact assessments and investigations.
  • Function as a subject matter expert for autologous T-cell therapies and manufacturing technologies.
  • Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.
  • Present complex technical topics internally and externally.
  • Share operational and process leanings with the rest of the manufacturing network


Qualifications:

  • Bachelor's or Graduate degree in Chemical Engineering, Biomedical Engineering or Life Sciences with more than 5 years of experience in Biotech industry. Familiarity with cell therapy processes and cGMPs is preferred.
  • Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.
  • Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
  • Experience assimilating large data sets in support of batch history sections for regulatory submissions. Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.
  • Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
  • Ability to assess risk and develop contingency plans for process risks
  • Able to manage time and elevate relevant issues to project lead and line management.
  • Detail oriented with excellent verbal and written communication skills.
  • Strong interpersonal and leadership skills to work with teams in different functions and organizations.


Create a job alert for this search

Process Engineer • Seattle, Washington, United States

Similar jobs

Software Engineer (Mission Sim)

Anduril Industries, Inc.Seattle, WA, United States
Full-time

Anduril Industries is a defense technology company with a mission to transform U.By bringing the expertise, technology, and business model of the 21st century’s most innovative companies to the def... Show more

 • Promoted

Mechanical Project Engineer – Industrial Gas Systems

NXT Talent StudioKent, Washington, United States
Full-time
Quick Apply

NXT Talent Studio | Empowering Careers.Our client is a premier global provider of specialized, high-pressure industrial gas systems.They specialize in the design and manufacture of custom, built-to... Show more

Validation Engineer

Bristol-Myers SquibbPicnic Point-North Lynnwood, WA, US
Full-time +1

Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optim... Show more

 • Promoted

Senior Software Test Engineer

Insight GlobalEverett, WA, United States
Temporary

Job Title: Senior Software Test Engineer.Location: Everett, WA, 5 days a week onsite.An employer is looking for a Sr.Software Test engineer to work on their thermal camera.The camera is an inspecti... Show more

 • Promoted

Process Optimization Specialist

Columbia DistributingKent, WA, United States
Full-time

Process Optimization Specialist.The Process Optimization Specialist is an individual contributor responsible for designing, improving, and standardizing operational processes to drive safe, complia... Show more

 • Promoted

Longline Chief Engineer

Coastal Villages Region FundSeattle, WA, United States
Full-time

Coastal Villages Longline, a subsidiary of Coastal Villages Region Fund, is currently seeking applications for a Chief Engineer to work aboard one of our Freezer Longliners.The primary job responsi... Show more

 • Promoted

Hiring: Process Engineer || Seattle, WA

Sunrise SystemsSeattle, Washington, United States
Temporary
Quick Apply

Duration: 12 Month Contract (Possible extension based on work performance).Primary responsibilities would include, but are not limited to:.Author study protocols and technical reports, and revise p... Show more

Principal Mechanical Engineer

LumicitySeattle, WA, United States
Full-time

We are looking for an exceptional mechanical engineer who's worked on extremely difficult products from 0-1.Extensive background in physical product development, including leading designs through p... Show more

 • Promoted

Sales Engineer - WA

Astrodyne TDISeattle, WA, United States
Full-time

Astrodyne TDI is looking for a Sales Engineer (SE) in the Mid-West area as part of our expansion plan for increased direct selling in North America.The SE is responsible to increase and improve sal... Show more

 • Promoted • New!

QA Engineer I: 24-01772 (No C2C)

Akraya IncSeattle, Washington, United States
Temporary
Quick Apply

Primary Skills: QA Testing, Appium, Automation, Selenium.Location: Seattle, WA/ San Francisco, CA (.Work for the world s Largest E-commerce company.Collaborate with Development, Product Managers, a... Show more

NDE Process Engineer

AAA USAEverett, Washington, United States
Full-time
Quick Apply

Must be willing to travel/temporarily relocate to Tukwila, WA.Paid Travel and lodging assistance available.Boeing develops, manufactures and services commercial airplanes, defense products and spac... Show more

Senior Weld Process Engineer

ASTTacoma, WA, US
Full-time
Quick Apply

At AST, we enhance the efficiency, productivity, and safety of flexible  aseptic manufacturing processes  for the worldwide Life Science Industry by offering innovative products, servic... Show more

Mission Platform Engineer: Kubernetes & APIs

Palantir TechnologiesSeattle, WA, United States
Full-time

A leading software company in Seattle is seeking a Software Engineer - Mission Manager to develop and manage software solutions for US Government clients.The ideal candidate will have a strong back... Show more

 • Promoted

Operations Engineer

Savers / Value VillageBellevue, WA, US
Full-time

Job Title: Operations Engineer.As one of the largest for-profit thrift operators in the United States, Canada and Australia for value priced pre-owned clothing, accessories and household goods, our... Show more

Microvellum Engineer - WA STATE

WoodJobsSeattle, WA, United States
Full-time
Quick Apply

Job Title: Microvellum Engineer - WA STATE</b></p> <p style="margin-bottom:11px"><b>Company: WoodJobs.About Us</b></p> <p style="margin-bottom:... Show more

Process Engineer

TSR ConsultingBothell, Washington, US
Full-time

Job Title: Senior Specialist – MSAT Process Engineering.Make your application after reading the following skill and qualification requirements for this position.Schedule: Monday–Friday, Standard Bu... Show more

 • Promoted

NPI Engineer - Additive Manufacturing

Alexander Daniels GlobalUSA, Washington, Seattle
Full-time
Quick Apply

POSITION SNAPSHOT: Our Client is seeking a highly skilled New Product Introduction (NPI) Engineer to lead the development and industrialization of additive manufacturing components from concept th... Show more

Engineer 2

eTeam IncSeattle, Washington, United States
Full-time
Quick Apply

An Engineer 2 is part of a key team of Technology professionals that applies scientific, mathematical and social principles to design, build, and maintain technology products, devices, systems and ... Show more