Senior Process Engineer

About the role

You've worked hard to become the professional you are today and are now ready to take the next step in your career. This role offers you the opportunity to apply your skills, experience, and passion towards achieving your career goals within Amgen.

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 equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and stay in sync with pertinent 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.
• System guidance to identify performance risks and implement risk reduction strategies.
• Provide problem-solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• 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. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems.
• 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.

Qualifications

• Doctorate degree OR Masters degree and 2 years of Engineering experience OR Bachelors degree and 4 years of Engineering experience OR Associates degree and 8 years of Engineering experience OR High school diploma/GED and 10 years of Engineering experience.
• Bachelors degree in Chemical or Mechanical Engineering with 6+ years' of relevant work 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.
• 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.
• Ability for domestic/international travel (~10%).