This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
In this vital role, you will work in a dynamic production environment at the Amgen Thousand Oaks Drug Product Packaging & Assembly plant supporting flexible and agile device assembly and packaging organization providing product in support of clinical trials across the globe and testing for device development. Under general supervision, employee will perform semi-complex processes operations in the Manufacturing area.
Job Responsibility:
Executing drug product packaging and assembly activities
Support planning & organization (time, staff, lines, materials, equipment)
Organize and lead team meetings
Supporting problem-solving sessions by serving as SME
Divide work/tasks by providing clear guidance and instructions to the team
Drive continuous improvement with the team and act as coach for production activities
Collaborate with Line Owner and FLM on process/equipment investigations
Fill gaps in the production lines and support as required
Performing initial review of manufacturing batch records
Maintaining a safe environment while adhering to compliance standards
Crafting and/or revising standard procedures
Elevating critical and impactful events to management
Utilizing appropriate systems for job duties (SAP, MES, QMTS, and LIMS etc.)
Provide SME support to Line Owners and NPI leads as needed
Initiating quality records and supporting triage
Assembly of a variety of combination products such as Auto Injectors and Automated Mini Dosers utilizing Semi-Automated Assembly Equipment
Bottling of small molecule tablets via manual process or automated processing
Assembly of vial sleeve and label and packaging of -70-degree C product
Requirements:
High school/GED + 2 years Manufacturing or military experience
Associate’s + 6 months Manufacturing or military experience
Bachelor’s
CFR and Regulatory knowledge
Mechanical ability
Knowledge of WIP lab equipment and computers
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
Ability to understand and apply basic chemistry, biology and physical principles
Basic troubleshooting skills on Purification equipment
Excellent written and verbal communication skills
Ability to prioritize tasks and work in a challenging and fast-paced work environment
Nice to have:
CFR and Regulatory knowledge
Mechanical ability
Knowledge of WIP lab equipment and computers
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
Ability to understand and apply basic chemistry, biology and physical principles
Basic troubleshooting skills on Purification equipment
Excellent written and verbal communication skills
Ability to prioritize tasks and work in a challenging and fast-paced work environment
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible