One Amgen Center Drive Thousand Oaks, CA 91320 | Contract
Qualifications: BS in Chemical Engineering or Mechanical Engineering 1-2 years general engineering experience Demonstrated Competencies/Skills: 1) Independent thinker with demonstrated skills working in teams 2) Strong Interpersonal and communication skills (oral and written)
Top 3 Must Have Skill Sets:
*Knowledge of primary containers or pharmaceutical packaging *Hands on testing experience-testing packaging (pharmaceutical packaging) -method development/qualification for testing *Project management-ability to keep track of samples and requirement to make sure it gets pushed through 1-2 years of experience idea-will take someone with only schooling background-BA/BS required
Job Details: This position will apply engineering principles to help execute the proper design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. In particular, experience or knowledge of container closure integrity testing is a bonus. The position requires organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment. This position is minimally responsible and accountable for the following:
1) Conduct tests and evaluation leading to the recommendation and selection of primary and secondary packaging materials for both large and small molecules product.
2) Write test protocols; perform technical evaluations and submitting testing results to support technical assessment reports used to justify the use of selected materials.
3) Support the development of SOPs and Tests Methods
4) Provide support to other engineers for various projects such as technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes 4) Provide support to line trials and packaging qualification activities prior to introduction of any new or change in components/processes
5) Ensures cGMP and regulatory compliance are met
6) Ensures that change control procedures are followed working with QA and Regulatory to implement changes
7) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.
8) Provide support in the assessment, development, and implementation of solutions for complex problems relating to packaging or packaging systems.