Process Analytical Engineer

ProcessAnalyticalEngineer

What youwill do

In this vital role you will join the Facilities & Engineering (F&E) group andbe responsible forplanning executing and documenting the qualification calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen North Carolina (ANC). This role includes hands-on troubleshooting and root cause analysis for analytical and laboratory systems coordination of vendor support and repairs execution and tracking of calibration maintenance and requalification activities through the Computerized Maintenance Management System (CMMS) Maximo and direct support for manufacturing operations to improve equipment uptime and reliability. You will also author own and approve Validation Life Cycle documents for computer-related systems including responsibility for Data Integrity testing and business administration of laboratory computer-related systems.

• Support commissioning qualification validation and system lifecycle documentation tomaintaincompliance and operational readiness.

• Partner closely with manufacturing teams to resolve issues improve system reliability and minimize operational downtime.

Key responsibilities:

• System ownership reliability and operations

• Work with the capital project team to ensure systems are installed andoperatesafelycomply withpertinent environmental health and safety practices rules and regulations and meet Amgen global engineering and design requirements.

• Serve asSystemOwner and Business Administrator foranalyticalequipment.

• Lead or work with teams in design development andselectionof new systems instruments calibrationcapabilitiesand consumable components.

• Development of laboratory equipment specifications touse for procurement of new laboratory equipment and instruments.

• Maintaining a current working knowledgeregardingregulatory requirements for equipment qualification and calibration.

• Support in generation and resolution of protocol discrepancies as.

• Alerting Quality Control Management if equipmentfails tomeet calibration or qualification requirements and conducting impact assessments/investigations as.

• Lead the development of calibration/maintenance programs ensure the availability of spare parts schedule repairs and maintenance and coordinate maintenance execution to keep systems in proper working order and minimize disruption to laboratory activities.

• Participation in technical project teams to function as a subject matter expert on instrument validation regulations and procedures.

• Evaluatethe capabilitiesof current and potential suppliers and assessnew technologiesthat could provide cost savings throughput or other unique capabilities to Amgen manufacturing.

• Writing/contributing to equipment operating procedures and manuals.

• Designing and conducting training formanufacturingstaff and other department staff as applicable.

• Own and project manage change controls while meeting applicable change control metrics.

• Preparing and presenting periodic management updates on activities to senior management.

• Conduct periodic reviews of instrument validation as part of validation life cycle.

• Validation compliance and quality systems

• A key contributor to Data Integrity Assessments for Lab systems

• Support Amgens laboratory systems validation and Data Integrity philosophy during audit interactions.

• Supportadditionaltasks andprojects asassigned by management.

• Cross-functional support projects and continuous improvement

• Develop coordinate analyze and present results for operational issues and engineering projects

• Provide technical supportforcommercial and clinical manufacturing as needed.

• Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.

• Identify support and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.

• Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and support interactions with regulatoryinspectorsas necessary.

• Apply basic engineering principles and practices in support of daily operation maintenance and troubleshooting of plant and process systems.

• Monitor systems toidentifyperformance risks and implement risk reduction strategies.

• Provide troubleshooting support to reduce production downtime including leading and/or supporting technical root cause analysis and implementation ofcorrective/preventive action; support may beoutside of normal working hours including nights weekends and holidays.

• Support new product/technology introductions by performing engineering assessments implementing equipment modifications and supporting engineering runs.

• Advance the use of condition-based and predictive maintenance practices by incorporating advanced data analytics where applicable.

• Lead investigations of abnormal conditions through Deviation and related business processes.

What we expectofyou

We are all different yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

• Masters degree

OR

• Bachelors degree and2years ofcGMP laboratoryanalytical instrument validation and/or Process Engineerexperience

OR

• Associates degree and6years ofcGMP laboratoryanalytical instrument validation and/or Process Engineerexperience

OR

• High school diploma / GED and8years ofcGMP laboratoryanalytical instrument validation and/or Process Engineerexperience

Preferred Qualifications:

• Bachelors degree in engineering or related technical field

• Laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation.

• Knowledge of themethodologyand instrumentation and analytical techniques used for biopharmaceutical testing.

• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.

• Demonstrated success in managing an equipment qualification or maintenance program.

• Ability to provide On-Callsupportcoveragenights and weekends on a rotating basis.

• Position requires strong written and verbal skills and the ability to work withminimumdirection.

• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.

• Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.

• Ability to function within cross-functional teams and embrace a team-based environment.

• Work schedule flexibility asto support 24/7 operations.

• Ability for domestic/international travel.