Amgen Process Development Sr.Engineer - Commissioning and Qualification in Juncos, Puerto Rico
Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for a Process Development Sr. Engineer – Commissioning and Qualification to join AML’s Process Development 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 role of the Process Development Scientist/Engineer - Commissioning and Qualification is to independently build qualifications strategies for new processes, new capital equipment and changes to current processes. Become the C&Q SME to continuously improve the commissioning, characterization and validation procedures and guidelines to ensure quality, compliance and efficiencies in support of Drug Product manufacturing facilities of oral dosage form and parenteral products including all process stages from formulation, filling, inspection, assembly, and packaging. The candidate will develop a deep understanding of the operations to become a subject matter expert to support activities including new product introduction, commercial support, improvement of existing processes and acquisition on new technologies. The candidate will have good documentation skills to write reports that can be used in regulatory audits.
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Serve as commissioning and qualification SME within the drug product PD organization.
Implement changes to commissioning, characterization and qualification procedures to improve based on lessons learned
Train others on C&Q current GMPs
Change control validation assessments
Support regulatory audits as related to qualification strategy and implementation approach
Available to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.
Meet specific project goals and timelines.
Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to complete investigations.
Communicates and/or presents scientific/ technical information within area of expertise across projects within a function/department, and occasionally to the external scientific community (i.e. regulatory agencies, review boards, conferences)
Supervise, coordinate and review work of a small team on a project basis.
May develop supervisory and mentoring skills.
Contributes to and may author scientific/technical documents (i.e. posters, presentations, publications, regulatory marketing applications, patent applications, technical reports, investigation reports)
May represent the department on project teams under supervision of a senior scientific staff member.
Adheres to company policies and procedures to ensure a continuous state of compliance
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Share knowledge to develop the teammates in expertise subject area.
Independently author and review protocols, experiments, scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
Generates robust and reliable data in compliance with the respective protocol, methods or SOPs
Monitor field of expertise, including literature and technology development, and communicates observations.
Apply knowledge of scientific/engineering principles and practices outside of area of expertise to broad variety of assignments in related fields
Basic education & experience
Master’s degree in Engineering and 3 years of experience in a GMP regulated industry.
Bachelor’s degree in Engineering and 5 years of experience in a GMP regulated industry.
Hands on experience on cGMP, regulated industry
Shown leadership developing validation strategies with successful results
C&Q certifications for pharma, combination products or biologics
Working knowledge on establishing user requirements, risk assessments, test case development and GxP regulations
Excellent communication skills: oral and written. Interacts optimally with variety of communication and working styles.
Fully bilingual in Spanish and English
Demonstrated strong problem solving and conflict resolution
Demonstrated leadership skills, initiative and self-motivation.
Excellent time and project management skills to deliver projects on time and budget.
Great teammate 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.
Computer literacy (Windows environment: Word, Excel, Power Point, Minitab
Our broad approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’. We offer an outstanding 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 passionate about your well-being too.
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.
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.