Amgen Process Development Sr Engineer -Packaging 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 Sr Engineer – Packaging 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 Sr. Engineer - Packaging utilizes physics, engineering and chemistry principles coupled with sophisticated and diverse materials science understanding and principles to assist in the evaluation, design, qualification and implementation of packaging components and the associated systems such as documentation, equipment and processes. A solid understanding of common materials utilized in pharmaceutical packaging is important in fulfilling this role. Key Material knowledge requirements of the structural components and chemical properties of glass, polymers, adhesives, inks, varnishes and paper is integral in the day to day oversight of this role. Understanding of packaging manufacturing equipment and processes and how materials interact with this is crucial for the position. This role will have some entry level management potential and will also utilize excellent organizational, project management, technical problem solving and communication (written and verbal) skills, with the ability to work in teams and adapt to a constantly evolving environment 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. 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:
Evaluation, recommendation and selection of new packaging materials for both large and small molecules' product.
Assessing sophisticated problems relating to materials, recommending and implementing solutions
Write test protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.
Representing AML Process development for final drug product as required
Technology transfer from to commercial for packaging components and equipment processes
Prioritize to ensure all projects are managed within expected due dates
Lead and present new packaging ideas, concepts and design ideas to the Product Development team.
Ensures cGMP and regulatory compliance are met
Accountable for packaging equipment selection to support new product introductions, capital projects and productivity projects
Ensures that change control procedures are followed working with QA and Regulatory to implement changes
Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed
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 following all pertinent environmental health/safety practice, rules and regulations.
Share knowledge to develop the teammates in expertise field.
Independently author and review protocols, experiments, scientific reports, summary documents, sophisticated 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 field expertise to broad variety of assignments in related fields
Basic education & experience
Doctorate degree in Engineering
Master degree in Engineering and 3 years of experience in GMP regulated environment
Bachelor degree in Engineering and 5 years of experience in GMP regulated environment
Packaging materials experience within the Pharma/Bio industry
Hands on experience specifying, installing and qualifying packaging equipment, printing systems and inspection systems.
Understanding of packaging material specifications including carton, inks, paper inserts, trays and other packaging materials.
Knowledge of packaging material standard testing and qualifications
Preferred educational background; Mechanical, Electrical, Industrial or Computer Engineer within Manufacturing and/or Biomedical
Excellent communication skills: oral and written. Interacts effectively 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.
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.