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Principal Reliability Engineer **Biotech**

BEPC, Inc.

Principal Reliability Engineer **Biotech**

Irvine, CA
Full Time
Paid
  • Responsibilities

    Job Description

    PRINCIPAL RELIABILITY ENGINEER

     

    Expectations on the core knowledge and Skills for a Principal engineer candidate.

    There are different possibilities on engineers profiles, project oriented, production and manufacturing oriented, Maintenance and reliability oriented.

     

    The Principal Engineer will lead implementation and sustainability efforts for Factory of the Future with Analytics Intelligence coupled with a practical approach.

    KEY RESPONSIBILITIES:

    • Drive the development and manage the execution of highly complex projects and new technologies and innovation (including writing and executing protocols) on a platform which includes multiple product lines to qualify and validate manufacturing equipment processes; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion.

    • Integrate operation equipment with controls, automation, and SCADA systems.

    • Initiate and lead the identification and ensure implementation of opportunities to optimize/improve manufacturing and/or facilities processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design on new products and/or processes, etc. are up to standards.

    • Train, coach, and guide lower-level employees on highly complex procedures, be the change agent .

    • Lead and establish highly complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).

    • Analyze and resolve complex Manufacturing, Facilities and Compliance issues (e.g., CAPA, non-conformances, audit observations).

    • Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.

    • May be selected as an Independent Reviewer for design review.

    • Perform other duties and responsibilities as assigned, ability to fill in or support next level responsibility.

    REQUIRED QUALIFICATIONS:

    • Bachelor's Degree in Engineering or Scientific field.

    • Minimum of 8 years of experience facilities, reliability, and/or engineering.

     

    PREFERRED QUALIFICATIONS:

    • Medical device, pharma, or biotech cGMP industry experience.

    • Advanced degree is preferred.

    • Automation robotics design operations and troubleshooting.

    • Strong leadership skills and ability to influence change as a change agent working with small or large groups.

    • Experience in highly regulated process that are structured in a matrix approach.

    • Experience in leading contractors, vendors, or suppliers to execute successful assignments.

    • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills.

    • Ability to translate complex and technical information to all levels of the organizations.

    • Ability to interact professionally with all organizational levels along with being flexible to support off shifts as needed for projects or problem resolution.

    • Ability to manage projects from end to end to fully execute task or projects.

    • Proven expertise in usage of MS Office Suite; CAD experience preferred.

    • Experienced in Maxmio asset management along with an understanding on reliability.

    • Experience with problem solving tools to do root cause analysis in a team approach environment.

     

    1 YEAR CONTRACT LENGTH WITH POTENTIAL FOR EXTENSION