Career Category
Manufacturing
Job Description
Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for a various Specialists Manufacturing to join AML’s Inspection & Packaging a Non Standard Shift Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.
The department
The AML-1 Facility is the home of elite, Drug Product Inspection and Packaging Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best mammalian drug substance manufacturing facility in the world.
The Role
The Specialist Manufacturing role supports the enforcement of manufacturing/quality systems specific to the investigation and reduction of deviations in the AML1 -Drug Product Manufacturing Operations – Inspection and Packaging Operations. Various positions available.
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. In addition will conduct risk assessments to ensure controls are in place and to make recommendations to address any applicable mitigation.
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 Assessments as required to identify and understand risks and failure modes
Define CAPAs by
Evaluate process improvement opportunities
Negotiate Actions with Partners
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 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
Facilitate Process and Equipment Risk Assessments and make recommendations to mitigate risks
Participate in regulatory inspections
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications
Participate in the assessment or implementation of special projects or initiatives.
Basic qualifications and experience
Bachelor’s degree & 5 years of Manufacturing experience in a GMP regulated industry
Or
Master’s degree & 3 years of Manufacturing experience in a GMP regulated industry
Or
Doctorate degree
Beyond that, the preferred qualifications are:
Educational background in Life Science and/or Engineering.
Written and Verbal communication in English and Spanish
In-depth experience in Root Cause Analysis (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe).
Drug product 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 broad approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program – and on-site child care and fitness facilities – you will find us
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.
.
