Auto req 12606BR
Job Posting Title Engineer - Package Engineering
Career Category Operations
Employee Subgroup Hourly FT
Country (State/Region) United States - California
Location (City) Thousand Oaks
Amgen Job Description This position reports into the Package Engineering (PE) group under Global Drug Product and Device Development in Thousand Oaks, CA.
This position will be required to apply advance and diverse engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components, the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position.
The position will leverage 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 responsible and accountable for the following:
1) Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product.
2) Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.
3) Write Technical Specifications and Bill of Materials
4) Representing PE in Drug Product and Global Operation Teams
5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes
6) Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes
7) Ensures cGMP and regulatory compliance are met
8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes
9) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.
10) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.
Basic Qualifications Masters degree
OR
Bachelors degree & 2 years of directly related experience
OR
Associates degree & 6 years of directly related experience
OR
High school diploma / GED & 8 years of directly related experience
Preferred Qualifications MS in Packaging or Engineering
5 years of packaging/engineering experience with 2+ years within the Pharma/Bio industry
Demonstrated Competencies/Skills:
1) Independent thinker with demonstrated skills working in teams or leading project teams
2) Strong Interpersonal and communication skills
3) Ability to multi-task and manage timelines
