Sr Engineer I - Multiple Shifts Job at Amgen (Holly Springs)

Job Description

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. SR ENGINEER I – DOWNSTREAM – MULTIPLE SHIFTS. What you will do: Let’s do this. Let’s change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise and system ownership to support process operations, focusing on Downstream Process engineering.

Job Responsibility

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
Effectively collaborate with key customers and support groups to ensure reliable plant operations
Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities
Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, 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
Providing problem solving support to reduce production downtime
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

Requirements

High school diploma / GED and 10 years of Engineering experience OR Associate's degree and 8 years Engineering experience OR Bachelor's degree and 4 years of Engineering experience OR Master's degree and 2 years of Engineering experience OR Doctorate degree
Bachelor's degree in Chemical or Mechanical Engineering
6+ years' of relevant work experience with 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 required to support 24/7 operations, requiring occasional after-hours engineering coverage
Ability for domestic/international travel (~10%)

What we offer

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
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

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Sr Engineer I - Multiple Shifts

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