Assistant Quality Process Engineer Jobs in Raleigh, NC

HOW MIGHT YOU DEFY IMAGINATION?

You'veworked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills,experienceand passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over10 million patientsworldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility not only featuresthe best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integratessustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company.

Senior Process Engineer

Live

What you will do

Let'sdo this.Let'schange the world. In this vital role youwill 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 domainexpertiseand system ownershipto supportprocessoperations, focusing onDownstream Process engineering.

Responsibilities include:

• Provide system ownership forBiopharmaceutical process equipment.Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.

• Effectively 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 the availability of spare parts, andcoordinatingmaintenance activities to ensure systems are in proper working order.

• Ensure systems are installed and operatingsafetyand stayin syncwith pertinent environmental health/safetypractice,rulesand regulations.

• Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.

• System guidance toidentifyperformance risks and implement risk reduction strategies.

• Providing 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 theprocessequipment.

• Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments,identifyinggaps and owning their remediation, implementing equipment modifications, and supporting engineering runs.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. Theengineeringprofessional weseekenjoys challenges and is motivated to help serve patientswith these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master's degree and2years of Engineering experience

OR

Bachelor's degree and4years of Engineering experience

OR

Associate's degree and8years of Engineering experience

Or

High school diploma / GED and10 years of Engineering experience

Preferred Qualifications:

• Bachelor's degree in Chemical or Mechanical Engineering

• 6+years'of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environmentwith a focus onDownstreamunit 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 ofsafety 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 ateam-basedenvironment that relies on communication for effective decision-making

• Strong leadership, technical writing, and communication/presentation skills

• Work schedule flexibility asrequiredto support 24/7 operations, requiring occasional after-hours engineering coverage

• Ability for domestic/international travel(~10%)

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

Amgen offers a Total Rewards Plancomprisinghealth and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.