Career CategoryManufacturing
Job DescriptionAssociate ManufacturingWhat you will doLet's do this! Let's change the world! 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. This individual will be responsible for performing the following:
- Executing drug product packaging and assembly activities, respectively.
- Support planning & organization (time, staff, lines, materials, equipment).
- Organize and lead team meetings.
- Supporting problem-solving sessions by serving as SME as needed.
- 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 and by identifying additional preventative measures.
- 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.
- Label printing of primary and secondary labels in support of the label and packaging work stream utilizing multiple systems such as EDMQ, EPIC, MES, SAP and LabelView 14.
- Detailed and accurate documentation will be performed in an Electronic Batch Record (EBR) through the Manufacturing Execution System (MES) or in paper batch record.
- Traditional Label and Pack operation.
- Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance.
- Performing and monitoring critical processes with the ability to perform basic troubleshooting.
- Performing in-process sampling of equipment and operating analytical equipment.
- Maintaining an organized and clean workspace.
- Working in a clean room environment wearing closed toe shoes, lab coat, hairnet, beard cover and gloves when performing work.
- Drafting and revising documents (SOPs, MPs).
- Identifying, recommending, and implementing improvements related to routine functions.
- Performing activities that include periods of rigorous, repetitive work.
- Working around high-pressure systems and occasionally work around heavy equipment.
Must be available to work various shifts as needed (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:- High school/GED + 2 years Manufacturing or Operations work experience OR
- Associate's + 6 months Manufacturing or Operations work experience OR
- Bachelor's
Preferred Qualifications:- 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 with the ability to effectively communicate thoughts and ideas.
- Ability to prioritize tasks and work in a challenging and fast-paced work environment.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- 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, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range70,985.20USD -96,038.80 USD
