Job Title: Sr. Engineer, Facilities and Engineering
Job Number: 29775
Location: Santa Monica, CA
We are seeking a highly motivated individual for the role of Senior Engineer, Facilities and Engineering, to work in an exciting new area of Cell Therapy at Neogene Therapeutics. This role reports directly to the Facility and Engineering Lead in Santa Monica, CA. The Senior Engineer, Facilities & Engineering is a key site operations representative. The Senior Engineer will be responsible for completing tasks which support the day-to-day operations and deliverables to the business, including design, development, implementation, and analysis of technical products and systems. Individual will also perform equipment engineering design evaluations and maintenance activities.
- Aid in development, implementation, and maintenance of a fit for purpose Asset Lifecycle Management System for GMP and non-GMP assets.
- Aid in development, implementation, and maintenance of a fit for purpose Calibration and Maintenance Program for non-GMP and GMP Assets.
- Ensures all site Maintenance activities are completed by the original due date or extended if due date cannot be achieved.
- Responsible for aiding in selection of vendors, execution of work orders by vendors and acting as a primary point of contact for facility maintenance services at the Santa Monica facility locations.
- Aid in management of activities related to facility operational readiness including equipment procurement, installation, commissioning and qualification of analytical and facility equipment.
- Define and oversee execution of commissioning and qualification plan for existing equipment and systems.
- Develop equipment and system specifications, procure, install, and oversee execution of commissioning and qualification of new equipment and systems.
- Develop and revise Standard Operating Procedures (SOPs) and associated training for Facilities and Engineering department.
- Partner with operations to align Facilities and Engineering plans with overall research and clinical plans.
- Provide oversight and support for Facilities and Engineering programs to ensure compliance with necessary Environmental Health and Safety regulations.
- Provides Engineering and Maintenance support to troubleshoot and improve/maximize the performance of equipment and processes.
- Maintain documentation associated with facilities, maintenance and affected manufacturing processes.
- Complete on time project updates, development plans and self-assessments.
- Participate in design and/or code reviews as needed.
- Minimum required education/experience for BS 7+ years, for MS 5+ years or for PhD 2+ years.
- At least 5 years of pharmaceutical or biotech industry experience in increasing levels of responsibility and operational excellence or Lean Facility and Engineering principles
- Minimum of 5 years of people management experience.
- Clear understanding of GMP process.
- Organization skills for day-to-day activities and excellent communication and interpersonal skills.
- A strong work ethic and sense of purpose with a demonstrated ability to identify, analyze and solve problems.
- Ability to drive safety, quality, functional, technical, and operational excellence.
- Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
- Ability to make timely decisions and knowing when to escalate and when to delegate.
- Proficient understanding and application of principles, concepts, practices, and standards.
- Wide range knowledge of industry practices, cell therapy Facility and Engineering experience highly desirable.
- Develop solutions to complex problems independently.
- Refer as necessary to established precedents and policies or use original thinking.
- Work is performed under minimal direction.
- Assists in determining objectives of assignment.
- Plan schedules and arranges own activities in accomplishing objectives.
- Work is reviewed upon completion for adequacy in meeting objectives.
- Provides support to upper management and accomplishes tasks through direct supervision of entry-level exempt employees and support contractors as needed.
- Provides direction to subordinates based on general policies and management guidance.
- Must have very strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.
- Must be able to update procedures and modify processes to simply their complexity and improve efficiencies.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must demonstrate the ability to learn new material quickly and demonstrate high potential for continued professional growth within Facilities and Engineering.
We offer the opportunity to join a highly dynamic growth-stage biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.