Downstream System Owner

Amgen • Thousand Oaks, CA

1d • Onsite

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 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.

Requirements

• Master’s degree OR Bachelor’s degree & 2 years of engineering and/or manufacturing experience Or Associate’s degree & 6 years of engineering and/or manufacturing experience Or High school diploma / GED & 8 years of engineering and/or manufacturing experience
• Bachelor's degree in engineering or another science-related field
• 7+ years of relevant work experience with 5+ years’ experience in operations/manufacturing environment
• Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
• Knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
• Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
• Experience with combination product / medical device quality systems verification
• Process equipment knowledge – basic principles of cell culture, fermentation, purification, filling
• Equipment knowledge of downstream purification equipment: Chromatography, Filtration, Single-Use Systems
• Process automation knowledge – fundamental understanding of automation infrastructure
• Strong communication and technical writing skills
• Strengths in facilitation and collaboration / networking
• Experience in developing SOPs and delivering training
• Individual must be a standout colleague prepared to work in and embrace a team-based environment that relies on collaboration for effective decision-making
• Basic understanding of process improvement methodologies to mature and improve business performance (examples: PDCA, LEAN, Six Sigma, etc.)

Nice To Haves

• Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus

Responsibilities

• Support manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO).
• Partner with automation, maintenance, project management, corporate engineering, and manufacturing to develop and lead all aspects of the operation and reliability of equipment while driving safety and quality compliance.
• Support the department and capital projects and provide data to support business cases and long term strategy.
• Provide direct engineering technical support.
• Model leadership behaviors and positive values to create a positive working environment.
• Be individually accountable for consistent equipment performance and reliability.
• Be accountable for assigned results on key capital projects.
• Suggest design modifications to address risks and design in quality and safety.
• Provide oversight for verification work developed by outsourced/contract verification staff.
• Act as a liaison between Engineering, Automation, Maintenance, Instrumentation, and Quality Assurance during project planning, execution, and closeout.
• Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety practices.
• Ensure safety during commissioning, validation, maintenance, and manufacturing activities.
• Initiate and drive continuous improvement activities and projects to completion.
• Participate or lead, when required, multidisciplinary site teams, e.g. Multi-functional Team, Root Cause Analysis lead.
• Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
• Provide ad hoc technical support and guidance for manufacturing and maintenance.
• Mentor and guidance to project teams and engineers using risk-based approaches.
• Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections.
• Participate in internal audits and assess in conjunction with quality assurance.
• Assist in developing and maintaining business metric performance.

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: Mid Level
• Number of Employees: 5,001-10,000 employees