Technical Operations

Senior Engineer, Facilities & Plant Engineering (2189-U-650-RES)

ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer.  Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments. 

Our people are our greatest asset, they bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.

The Sr. Engineer, Facility and Plant Engineering is a Subject Matter Expert (SME) with demonstrated advanced knowledge and understanding of Plant Engineering, HVAC, Utilities and Building Automation design practices within the biopharmaceutical cGMP environment. The incumbent will provide leadership and mentoring for more junior engineering staff as the department continues to grow.

This role is a key position for ArsenalBio and the successful candidate will significantly improve our bioprocesses used to produce engineered toxin bodies. This is an exciting and dynamic opportunity for you to contribute to the development of new principles and concepts and to be challenged and lead change from an engineering perspective. The individual will report to the Senior Director, Facilities & Engineering.

This role provides technical support for the manufacturing facility, including the design and specification of plant utilities and building management platforms. The Sr. Engineer will be part of a dynamic group of engineers who will be responsible for capital and expense project delivery, equipment & Utility trouble shooting, root cause analysis and providing optimization strategies for process support equipment within multi-product, FDA regulated cGMP facilities. 

This role serves as subject matter expert for plant utilities including HVAC, Refrigeration and Building Management. Develop and execute engineering tests, FATs, SATs, commissioning test plans and train operations staff on new/revised operating procedures. Identifies equipment specific best practices and performs gap analysis between ArsenalBio and industry best practices.

What You Will Do:

  • Serve as SME on Facility Engineering Design and Construction for laboratory and cGMP manufacturing expansion projects within Facilities & Engineering, sharing best practices, technical know-how and adding significant value to the group
  • Provide technical expertise to support process tech transfers and/or expense/capital projects through budget development, schedule development, resource planning, design, construction, commissioning and qualification activities
  • Champion and foster a positive safety culture in which we strive for zero workplace injuries, and actively contribute to continuous safety improvements
  • Provide technical leadership to monitor physical plant health through process monitoring and system reliability analyses
  • Specify process control strategies and oversee process automation system implementation and continuous improvements
  • Participate in gap analyses and risk assessments to support process tech transfers.
  • Author tech transfer related projects plans, assessments, and process validation protocols
  • Review and provide recommendations on design drawings, which may include PFDs that incorporate mass or energy balances and P&IDs, which include all line sizing, instrumentation and control philosophies. 
  • Interact with vendors concerning contracts of critical financial value and select vendors based on key performance criteria. 
  • Develop, manage and integrate key aspects of critical projects such as budget, schedules, resource planning
  • Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and complex systems.
  • Provide key input into the validation of process equipment and associated utilities.  Direct manufacturing and operations staff in the execution of validation protocols.
  • Primary point of contact for Facility and Utility equipment related troubleshooting
  • Owns and maintains the design and specification for equipment and instrumentation
  • Execute technical and scientific projects and initiatives including study plan and execution, writing technical reports, data analysis and interpretation to support development and manufacturing activities
  • Ensure quality and effectiveness of key results of major projects through sound design, early risk assessments, and implementation of effective risk mitigation strategies
  • Respond technically for quality system responsibilities: process-related investigations; product impact assessments, change control and CAPA
  • Participate as technical expert in site regulatory inspections as needed
  • What You Will Bring:

  • BS/MS in engineering discipline preferred – Chemical or Mechanical Engineering, or related field 5+ years experience in upstream or biologics process development, technology transfer, pilot plant, or manufacturing support.
  • 5+ years applicable equipment and process system experience.
  • Advanced knowledge of Biologics Process Engineering Design and Construction
  • PE licensure is preferred
  • Experience in the selection and design of leading industrial control systems including Siemens Desigo, Rockwell, Allen Bradley, and Siemens Simatic / Win CC
  • Prior experience in biological/viral commercial GMP facility
  • Validation experience related to equipment, utility and process systems, including requirements for documentation and testing.
  • Thorough knowledge of cGMP guidelines, experience in generation of controlled documents and extensive experience in equipment start-up and validation.
  • Excellent communication skills, both written and verbal.
  • Skill in listening to and understanding others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentation
  • We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

    To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or Arsenalbio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.

    Apply     

    ArsenalBio was formed by its investors and scientific founders to discover, develop and commercialize curative and safe cellular therapies for patients with life threatening diseases, initially cancer.

    We believe the most productive and secure route to achieving this goal is to build scaled platforms of technologies challenged with scientific questions to yield informative data from hypothesis driven, well controlled experiments. These data will inform the design of ambitious, best-in-class, lead compositions. Our leads will be rigorously evaluated and honed until we are convinced our matured leads, called development candidates, can be prepared for testing in needy, and vulnerable patients.

    Our products will be designed to speed the transition of cell therapy from hospital-based to outpatient treatments, increasing access to more patients at lower cost to patients, health systems, and insurers.

    To achieve this mission, we are building diverse teams of talented, curious, and caring individuals who believe in our mission and our vision to be sustainable in our business plan, our work habits, and our personal lives.

    Our values create: a foundation for mutual respect, an engaging harmony from many voices, and unselfish behavior to aid our colleagues.

    This is ArsenalBio.
    This is our Company.


    Ken Drazan, MD
    Founding CEO

    Benefits

    Best in Class Health & Wellness Plans

    Flexible Office Hours

    Paid Parental Leave

    Healthy Kitchen Snacks

    Daily Catered Lunches

    Free Onsite Fitness Center

    Unlimited Vacation Days

    Generous compensation and equity packages

    Commuter Benefits

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