Principal Manufacturing Systems Engineer

Amgen Inc.

3.6

(9)

Thousand Oaks, CA

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-180560

    Position summary

    intensification of Amgen processes.
    Responsibilities include:

    • Manage and lead process automation support teams for MCS Drug Substance manufacturing in Thousand Oaks, CA.

    • Network internally and externally to define problem statements and identify key technologies and potential solutions in the advanced automation and process control field.

    • Plan and implement change efforts for automation strategy for the company, beginning in the Manufacturing and Clinical Supply (MCS) organization.

    • Define the strategy for automation and process control within MCS Drug substance manufacturing. Partner with senior management within Process Development to secure resources for programs of critical importance.

    • Lead the team implementing the development strategy. As part of the Facilities & Engineering (F&E) group within the Manufacturing Clinical Supply (MCS) organization, the Principal Manufacturing Systems Engineering will work with the Senior Manager Engineering Manufacturing Systems at Amgen.

    This role is expected to provide leadership as follows:

    • Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy.

    • Partner with Process Development, Amgen IS, and commercial manufacturing teams to ensure compliant delivery of developed solutions.

    • Strategic and tactical management and leadership in providing day to day operational support and capital project support, mentoring, staff development, team productivity, and efficient use of available resources.

    • Develop support structures with internal/multi-functional teams for capital projects, plant support, and Amgen network-level initiatives execution.

    • Providing input into department objectives and establishing strategic direction within the Drug Substance Network F&E automation team.

    • Maintain and improve capabilities and automation systems reliability in partnership with F&E and plant leadership and other technical staff in the network, focusing on "predict and prevent" systems failures and recurrence avoidance. Strategize asset lifecycle management and long-range plans for equipment Maintenance.

    • Work with diverse groups (Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.

    • Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects, and implement.

    • Ensure site readiness and compliance for internal audits, external agency audits, and partner audits. Ensure the safety of all personnel during plant operations and engineering activities.

    • Ensure that all staff are adequately trained and follow all GMP standards and procedures.

    • Ensure Business Continuity, identify gaps and develop/implement solutions to close the gaps.

    • Develop and adhere to department budgets and spend for operational and capital expenses.

    • Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.

    Basic Qualifications:

    Doctorate degree and 2 years of Engineering experience
    Or

    Master's degree and 6 years of Engineering experience
    Or

    Bachelor's degree and 8 years of Engineering experience
    Or

    Associate's degree and 10 years of Engineering experience
    Or

    High school diploma / GED and 12 years of Engineering experience.

    Preferred Qualifications:

    • Masters and/or Ph. D. in Chemical Engineering, Electrical Engineering, or related field.

    • 10-15 years experience working in the process automation field within the biopharmaceutical industry.

    • Ability to work independently and in small or large groups.

    • Demonstrated proficiency in implementation of advanced process control applications in an industrial setting (e.g. Model Predictive Control, Adaptive Control).

    • 5-10 years experience as an engineer or system administrator within the DeltaV Distributed Control System, Rockwell, ABB Robot, Mitsubishi Roller Bottle machine, Plant utilities, cleaning system and Building management system.

    • Greater than 4 years proven experience leading matrixed teams.

    Thrive

    What you can expect of us

    As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

    Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

    • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

    • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

    • Stock-based long-term incentives

    • Award-winning time-off plans and bi-annual company-wide shutdowns

    • Flexible work models, including remote work arrangements, where possible

    Apply now

    for a career that defies imagination

    Objects in your future are closer than they appear. Join us.
    careers.amgen.com

    Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

    Salary Range
    159,910.00 USD - 186,712.00 USD

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging