Sr. Associate Tech Engineering - Process Mechanics

Amgen Inc.

3.6

(9)

Juncos, Puerto Rico

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-190008

    Position summary

    , equipment calibration or standardization, upgrades, replacements or modifications to ensure that all manufacturing maintenance team operations and manufacturing activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards in a NON STANDARD SHIFT operations facility.

    Specific responsibilities include but are not limited to:

    • Troubleshoot, repair and/or restore manufacturing equipment Systems in compliance with all applicable industry standards, regulatory standards, and FDA standards.

    • Identify improvement opportunities and engage in projects to implement solutions them, including identifying the newest technology in the market.

    • Develop technical guides for repetitive tasks and train others for continuous team development.

    • Troubleshoot electrical problems of three phases, single phase and DC control circuits while following company safety rules and local and national electrical codes (NFPA, OSHA, etc.)

    • Support the line owners, system owners and project teams in the implementation of changes in equipment systems as part of change controls, CAPAs, work orders, preventive maintenance, etc.

    • Ensure that utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.

    • Provide training and ensure that the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.

    • May act as Team Leader and support with the coordination of daily shift support to the maintenance team

    • Assist the maintenance team during FDA and other regulatory agency inspections.

    • Assist with the investigation on work order completed in preventive maintenance, and corrective maintenance.

    • Facilitate routine audits of activities, documentation, operations, and related areas to ensure a continued state of compliance.

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The Sr. Associate Tech Engineering professional we seek is an individual contributor with these qualifications.

    The Basic Qualifications are:

    Master's degree

    OR

    Bachelor's degree and 2 years of maintenance experience

    OR

    Associate's degree and 6 years of maintenance experience

    Or

    High school diploma / GED and 8 years of maintenance experience

    Beyond that, the preferred qualifications are:

    • Educational background in Electrical, Mechanical, or Electronic Engineering Technology

    • Maintenance experience

    • Experience in GMP environment in the pharmaceutical, medical device or Biotechnology Industry.

    • Experience with Drug Product manufacturing technologies / equipment, specifically aseptic filling equipment and isolators

    • Technical knowledge in the following systems: Time pressure filling systems, Isolator technology, Isolator Air Handling Systems, Air visualization studies in Isolators, Cold Rooms, Glass Washers, and Autoclave.

    • Experience in multiple technical fields such as: instrumentation, electrical, mechanical, automation and operations related to Manufacturing areas

    • Experience in working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately.

    • Self-learner, curious and engaged in maintenance, automation, and control system technological trends to constantly develop technical competencies.

    • Strong understanding in electrical print reading, solid state drives and other motor control technologies using servo or steppers (Motor starters, SCR, VFD's)

    • Good communication and technical writing skills in both English and Spanish

    • Able to Support Operations in Non-Standard shifts that includes weekends, nights and/or holidays

    Thrive

    Some of the vast rewards of working here

    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.

    • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

    • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

    • Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

    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.

    .

    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