Senior Process Engineer

Amgen • Holly Springs, NC

9d • Onsite

About The Position

Amgen is seeking a Senior Process Engineer to join their Facilities & Engineering (F&E) group at their newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility combines disposable technologies with traditional stainless-steel equipment and integrates industry 4.0 capabilities and sustainability innovations. The role involves partnering with the corporate engineering team to design, build, commission, and qualify new equipment and systems for drug substance production, with a focus on Downstream Process engineering. The Senior Process Engineer will develop system ownership and domain expertise to support process operations.

Requirements

• Doctorate degree OR Master’s degree and 2 years of Engineering experience OR Bachelor’s degree and 4 years of Engineering experience OR Associate’s degree and 8 years of Engineering experience Or High school diploma / GED and 10 years of Engineering experience
• Bachelor’s degree in Chemical or Mechanical Engineering
• 6+ years' of relevant work experience
• 5+ years' experience in Biopharmaceutical operations/manufacturing environment with a focus on Downstream unit operations
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects
• Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
• Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
• Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
• Collaborative teammate prepared to work in and embrace a team-based environment that relies on communication for effective decision-making
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as to support 24/7 operations, requiring occasional after-hours engineering coverage
• Ability for domestic/international travel (~10%)

Responsibilities

• Provide system ownership for Biopharmaceutical process equipment.
• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems.
• Develop business cases for improvements, identify design requirements, and translate requirements into process equipment/system design, specification, and support construction, startup, and validation.
• Collaborate with key customers and support groups (e.g., Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.
• Develop equipment maintenance programs, ensure availability of spare parts, and coordinate maintenance activities.
• Ensure systems are installed and operating safely and in compliance with environmental health/safety practices, rules, and regulations.
• Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
• Provide system guidance to identify performance risks and implement risk reduction strategies.
• Provide problem-solving support to reduce production downtime, including leading and/or supporting technical root cause analysis and implementation of corrective/preventive actions.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations.
• Provide technical mastery and problem-solving leadership to proactively reduce production downtime.
• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment.
• Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments, identifying gaps and owning their remediation, implementing equipment modifications, and supporting engineering runs.

Benefits

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed