Specialist Manufacturing - DS Major Deviations
R-136338 Specialist Manufacturing - DS Major DeviationsLive
What you will do
Lets do this! Lets change the world! In this vital role you will have the outstanding opportunity to tackle 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 efficiently, you will also be involved in applying process, operational, scientific expertise, basic compliance knowledge, analytical & troubleshooting skills to support manufacturing operations.
Specific responsibilities include but are not limited to:
- Lead major/trend deviation investigations throughout the whole lifecycle, including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring investigation reports, leading Trackwise record, speaking publicly at regulatory inspections
- Facilitate Risk Assessments and author risk assessment reports
- Own corrective/preventive action records and lead implementations.
- Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.
- Provide troubleshooting support and may participate in regulatory inspections.
- Participate in the New Product Introduction (NPI) process to assess requirements for documentation, materials, training, and equipment modifications.
- May lead initiatives related to training strategies to support manufacturing areas.
- Participate on the assessment or implementation of special projects or initiatives.
- 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.
- Support non-standard shift organization, including weekends and extended hours as per business needs.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Specialist Manufacturing professional we seek is an individual contributor with these qualifications.Doctorate degree
Masters degree & 3 years of Manufacturing support experience in a GMP regulated industry
Bachelors degree & 5 years of Manufacturing support experience in a GMP regulated industry
Associates degree and 10 years of Manufacturing support experience in a GMP regulated industry
High school diploma / GED and 12 years of Manufacturing support experience in a GMP regulated industry experience
Beyond that, additional preferred qualifications are:
- Educational background in Life Science, Chemistry, Biochemistry, Industrial Biotechnology, Bioengineering, Chemical/Biochemical Engineering and/or Mechanical Engineering
- Strong Technical Writing and verbal communication skills in English and Spanish.
- In-depth experience in Root Cause Analysis (Fishbone, Six Boxes, Fishbone, 5 Whys, Kepner Tregoe).
- Detailed technical understanding of bio-processing unit operations.
- Compliance/Regulatory knowledge and audit interaction experience.
- Experience leading cross-functional teams for Root Cause Analysis and problem solving.
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
- Strong presentation and project management skills.
Some of the vast rewards of working here
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.
- 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Objects in your future are closer than they appear. Join us.careers.amgen.com
Join UsIf 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.