20 days old

Specialist Mfg - Major Deviations & Inspection Readiness

Juncos, Puerto Rico 00777
  • Job Code

Job ID: R-101935
Location: Juncos, PR, US 00777

The role

The Specialist Manufacturing position will support the Drug Substance Manufacturing Programs department specifically Major Deviations and Inspection Readiness area for AML6 and AML7 Drug Substance Plants. The role will apply process, operational, scientific expertise, compliance knowledge, and analytical skills. Will also support the Root Cause Analysis and robust CAPA identification for manufacturing operations and support systems.

Specific responsibilities include but are not limited to

  • Complete Root Cause Analysis
  • Apply Process Expertise - capable of understanding process monitoring parameters and control limits require to assess for potential causal factors
  • Assess process performance by observation of floor operations and review of performance data.
  • Support trouble shooting to identify Causal Factors and potential corrections
  • Evaluate manufacturing and operational procedures
  • Evaluate training requirements for technical aspects of the process
  • Identify training opportunities
  • Use and perform Risk Assessmentsas required to identify and understand risks and failure modes
  • Define CAPAs by
  • Evaluate process improvement opportunities
  • Negotiate Actions with Stakeholders
  • Deliver timely robust plan to address Root Cause
  • Perform Impact to Process /Equipment /System Assessment
  • Team with Product Development to understand potential impact to product quality attributes
  • Assess Equipment/Systems information for potential impact to product quality attributes
  • Assess for Data Integrity
  • Assess for Process/Cleaning Validation Impact
  • Author Investigation Report
  • Use Technical Writing techniques proficiently
  • Perform Data Verification
  • Ensure timely report approval
  • Support Peer Review
  • Follow current standard procedures/templates
  • Serve as SME to define deviation designation when called upon
  • Participate in regulatory inspections
  • Participate in the assessment or implementation of special projects or initiatives.

The department

The Drug Substance Manufacturing Programs team is accountable for ownership of major deviations, execution of risk management activities, and ensuring inspectional readiness across both AML6 and AML7 drug substance manufacturing. The team is also responsible for developing drug substance business unit staff training strategy including short-term and long-term plans, creation of new training curriculums and life cycle management of curriculums based on business needs.

Basic qualifications

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


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


Doctorate degree

Beyond that, the preferred qualifications are:

  • Education field in Life Science and/or Engineering.
  • Microbiology Background
  • In-depth experience in Root Cause Analysis (Fishbone, Six Boxes, Fishbone, 5 Why's, Kepner Tregoe).
  • Drug substance manufacturing experience
  • Strong Technical Writing Skills
  • Detailed technical understanding of bio-processing unit operations.
  • Skilled in performance of GMP production operations.
  • Compliance/Regulatory knowledge and interaction experience.
  • Experience leading cross-functional teams for RCA and problem solving
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Strong presentation skills.
  • Project management skills.
  • Knowledge of control charting.
  • Availability to support non-standard shift.

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.

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.

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.



Posted: 2020-07-16 Expires: 2020-08-16

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Specialist Mfg - Major Deviations & Inspection Readiness

Juncos, Puerto Rico 00777

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