Summary: The Senior Process Optimization Engineer independently leads the development of process optimization strategies and troubleshooting of operational issues in manufacturing, pilot plant, or capital project environments.
The role involves applying advanced engineering principles to design system modifications, analyze results, and present interpretations for projects of significant scope and complexity.
Responsibilities: Execute complex assignments requiring innovative engineering techniques.
Develop and enforce engineering policies and procedures across organizational units.
Supervise and coordinate a small team of engineers, associates, or technicians.
Apply advanced engineering techniques and extend expertise to diverse assignments.
Serve as a technical specialist, determining methodologies in assigned areas.
Plan and execute projects utilizing mature engineering knowledge.
Develop creative solutions to technical problems and system improvements.
Collaborate with cross-functional teams to define and recommend system modifications.
Partner with project managers to deliver projects within scope, budget, and timeline.
Coordinate with consultants, architects, and engineering firms for design development.
Manage budgets for projects or departmental operations.
Author, review, and approve engineering documents, such as URS, RD, DS, SOPs, PTCs, and maintenance master packages.
Execute or support FATs, SATs, IOQs, and PQs, ensuring compliance with engineering standards.
Troubleshoot and analyze equipment failures, recommending and implementing corrective actions.
Conduct root cause analysis investigations for equipment and systems.
Actively participate in risk assessments and continuous improvement initiatives, such as Kaizens and critiques.
Identify, evaluate, and implement process improvement opportunities.
Manage Amgen systems such as MAXIMO, CDOCS, QMTS, and GDMS.
Initiate, develop, and present change controls and CAPA plans.
Develop and maintain job plans and spare parts lists.
Provide technical support for high-skill equipment breakdowns and minimize operational downtime.
Generate training materials and conduct training on equipment and systems.
Skills and Knowledge: Expertise in pharmaceutical/biotech processes, GMPs, and validation practices.
Advanced skills in technical writing, project management, and problem-solving.
Proficiency in Amgen systems such as MAXIMO, CDOCS, QMTS, and GDMS.
Ability to independently manage multiple tasks and priorities.
Requirements Education: Doctorate in Engineering OR Master's degree with 3+ years of engineering experience OR Bachelor's degree with 5+ years of engineering experience.
Preferred Qualifications: Experience in managing change controls, CAPAs, and equipment failure analyses.
Proficiency in reviewing and authoring technical documents, such as SOPs, FATs, SATs, IOQs, and P&IDs.
Demonstrated experience with troubleshooting, risk assessment, and process improvements.
Strong collaboration, facilitation, and leadership skills.
Ability to manage vendor and contractor relationships effectively.
Shift: 8-hour shift | Monday to Friday | 8:00 AM to 5:00 PM Flexibility for after-hours support as required.