Amgen

Specialist Manufacturing - DS Process Risk Management

Employer
Amgen
Location
Juncos, PR, US
Posted
Sep 11, 2020
Ref
R-101717
Required Education
Bachelors Degree
Position Type
Full time
Summary

Are you a professional with a vast knowledge in manufacturing processes? Amgen is looking for a Specialist Manufacturing - to support a nonstandard work schedule, for our manufacturing operation at Puerto Rico site, Amgen Manufacturing Limited! As Specialist Manufacturing, you will bring forth out of the box thinking, an agile attitude, subject matter expertise and innate understanding of Drug Substance Manufacturing processes supporting to a large-scale 24/7 mammalian, and bacterial manufacturing plants.

The role

This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture, Bacterial Fermentation and Purification facilities., Your responsibilities include the execution of manufacturing/quality systems such as , risk management, deviations, process monitoring &validation, process improvements, procedures, training, and new product introductions.

To keep everything running smoothly, you will also be involved in applying process, operational, scientific expertise, basic compliance knowledge, analytical & troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

The departments

The AML-6 and AML-7 facilities are the home of best-in-class, multi-product Drug Substance Manufacturing Operations. The facilities highlight the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian & bacterial Drug Substance manufacturing facilities in the world.

Specific Responsibilities Include But Are Not Limited To:
  • Responsible for facilitating Risk Assessments, executing Gap Assessments, authoring investigation reports, execution of corrective actions.
  • Support equipment/system Root Cause Analysis investigations and support trend evaluations
  • May support establishment of process monitoring parameters and control limits.
  • Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process
  • May assist with generation and execution of process validation protocols and reports
  • May participate in regulatory inspections.
  • Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
  • Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
  • Assist manufacturing change owner on CCRB packages impacting the process.
  • Participate on the assessment or implementation of special projects or initiatives.
  • Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
  • Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
  • Provide troubleshooting support.
  • Support non-standard shift organization, including weekends and extended hours as per business needs.


Basic qualifications are:

Bachelor's degree & 5 years of Manufacturing experience within a GMP regulated industry

OR

Master's degree & 3 years of Manufacturing experience within a GMP regulated industry

OR

Doctorate degree

Beyond that, the preferred qualifications are:
  • Educational background in Life Sciences and/or Engineering.
  • Robust knowledge and proven successful track execution of Good Manufacturing Procedures.
  • Hands on experience with SAP, EBR, Change Control, Trackwise and Equipment Interphase (HMIs) systems.
  • Detailed technical understanding of drug substance unit operations.
  • Regulatory knowledge and interactions
  • Knowledge in Risk Management Process (i.e. Failure Mode and Effects Analysis (FMEA), Product Quality Risk Assessment Quality by Design Method (PQRA-QbD), Quality Risk Assessment for Equipment and Automated Systems (QRAES))
  • Participate and help lead cross-functional teams
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Organizational, technical writing and presentation skills.
  • Project management skills.
  • Knowledge of control charting.
  • Availability to support non-standard shift
  • Experience in Root Cause Analysis (Fishbone, 5 Why's, Kepner Tregoe)
  • Good documentation skills.
  • Excellent written and oral communication skills in English and Spanish.


The benefits

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.