Associate Manufacturing

Amgen • Thousand Oaks, CA

56d

About The Position

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. The Manufacturing Associate position is part of the Amgen, Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection team. This Associate position will be focused on: Performing 100% manual inspection, Post inspection packaging operation, Characterization and equipment management, Process improvement projects/assignments within operations, Quality systems (LIMS/MES/SAP/MAXIMO) support, Support new product introduction activities, Support clinical and commercial production, Maintain open communication between operations teams. This Associate position will be focused on manual visual inspection in manufacturing operations.

Requirements

• High school/GED + 2 years biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) work experience OR Associate’s + 6 months biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) work experience OR Bachelor’s

Nice To Haves

• Experience with manual visual inspection in a GMP regulated environment.
• Experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
• Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
• Demonstrated technical writing capability
• Knowledgeable of manual visual inspection background or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
• Demonstrated ability to work in a team

Responsibilities

• Perform 100% manual inspection
• Perform post manual inspection packaging operations
• Under minimal supervision, performs manufacturing unit operations according to Standard Operating Procedures
• Understand process parameters and can identify process anomalies
• Operate critical processing equipment
• Assist and implement continuous improvement solutions related to routine functions
• Assist in ensuring operations are completed per manufacturing schedule
• Resource related to processing operations on the mfg. floor
• Identify and propose solutions to complex problems
• Responsible for identifying and communicating problems during operations
• Perform initial review of manufacturing procedures/batch records
• Review, revise, and audit documents
• Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
• Provide hands-on training to others
• Provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents
• Applies research, information gathering, analytical and interpretation skills to problems of diverse scopes
• Utilizes basic project management skills to set project timelines and priorities-based project objectives and ongoing assignments
• Recognizes and escalates problems
• Able to establish working relationships with others outside area of expertise
• Ability and willingness to support flexible shift structure in support of operations (may include off-shift and weekends)
• Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles as appropriate for the position
• Organizational skills and an ability to perform assignments with a high degree of attention to detail
• Written and oral communication skills.
• Technical writing capability
• GMP knowledge with ability to interpret and apply applicable regulations
• Ability to understand processing methods for manufacturing area

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees