Amgen

Process Development Sr Associate (System owner)

Employer
Amgen
Location
Juncos, PR
Posted
Jan 25, 2022
Ref
R-136687
Required Education
Bachelors Degree
Position Type
Full time
What you will do

Lets do this. Lets change the world! In this vital role you will support the equipment life cycle for the Process Development Drug Product Laboratory and Compliance organization. Under general supervision, ensures laboratory equipment and instrumentation are fit-for-use by maintaining Maximo records and external service contracts up to date and coordinating operational windows for the implementation of maintenance and/or calibration routines. Generates unscheduled work orders and coordinates vendor, mechanic, electrician and/or instrumentation support for installation, maintenance, calibration, and/or troubleshooting. Conducts general troubleshooting of equipment issues and equipment verification.

Under close supervision, completes impact assessments for Out-of-Process-Tolerance instrumentation events.

Specific responsibilities include but are not limited to:
  • Serves as System Owner for Process Development Drug Product Laboratories equipment.
  • Execute corrective maintenance activities and find solutions for systems/equipment issues. Leads and supports investigations for Quality deviation events and supports compliance audits
  • Supports or implements Preventive Maintenance and Calibration Programs to Laboratory assets.
  • Uses CMMS to manage and document activities.
  • Engages vendor, mechanic, electrician and/or instrumentation support to ensure timely resolution of equipment-related issues to meet timelines and minimize downtime.
  • Evaluates OPT trends to seek efficiencies by adjusting instrument tolerance ranges and thus avoid nuisance OPT events.
  • Document equipment-related events/actions appropriately in Maximo work orders or in the designated electronic lab notebook system
  • Owns/Authors technical reports for OPT event impact assessments (TAs)
  • Seeks economical savings through comparative analyses of external service providers and their products
  • Monitor equipment / instrument obsolescence to prepare for technology transitions
  • Maintains equipment spare parts lists up to date.
  • Maintains team abreast of new equipment / instrumentation trends (such as Operations Alerts, software upgrades, etc.) to actively contribute to a compliance-minded environment
  • Responsible for complying with Good Manufacturing Practices and Good Documentation Practices
  • Participate in quality improvement efforts
  • Implement or coordinate the Commissioning, Qualification, and Validation strategies for laboratory equipment.
  • Be responsible for the Laboratory Equipment Maintenance.
  • Adheres to company policies and procedures to ensure a continuous state of compliance.
  • Supports internal/external audits and inspections.
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.
  • Support non-standard shift and extended hours including weekends, as per business needs.

What we expect of you

We are all different, yet we all use our outstanding attributes to serve patients. The Process Development Senior Associate professional we seek is a strong contributor with these qualifications.

  • Masters degree
  • OR Bachelors degree and 2 years of experience in laboratories, validation, or operations of GMP regulated industry.

Beyond that, additional preferred qualifications are:
  • Educational background in Life Science and/or Engineering
  • 5 years of experience in laboratories, validation, or operations of GMP regulated industry.
  • Prior equipment validation experience in Drug Product or laboratory environment.
  • Quality and compliance knowledge of regulations and expectations.
  • Experience in laboratory operations
  • Proven experience of improving processes using operational excellence
  • Excellent communication skills: oral and written in Spanish and English. Interacts effectively with variety of communication and working styles
  • Budget management experience
  • Demonstrated experience in problem solving and conflict resolution
  • Excellent time and project management skills to deliver projects on time.
  • Team player with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making
  • High quality and compliance mind set to work in a highly regulated GMP industry
  • Digital literacy (Windows environment: Word, Excel, Power Point, Minitab, Maximo
  • NC/CAPA owner

What you can expect of us

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

  • Vast opportunities to learn and move up and across our global organization
  • 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

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.


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.