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Associate Manufacturing

2 months ago

Thousand Oaks, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Associate ManufacturingLive

What you will do

Lets do this Lets 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.

    Able to regularly lift up to 35lbs, push and pull objects that require up to 50lbs of force, and work on your feet for long durations.

    Able to perform the list of physical movements that may be necessary to perform daily functions on the production floor: bending, reaching above the head, climbing, kneeling, squatting, stooping, walking upstairs, and standing on portable stairs or ladders up to 6 feet off of the ground.Win

    What we expect of you

    We 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 diploma / GED and 2 years of Manufacturing experience OR Associates degree and 6 months of Manufacturing experience OR Bachelors degreePreferred 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.Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

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 and bi-annual company-wide shutdowns

Flexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.comApplication deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.