Sr Process Engineer

Career Category

Engineering

**Job Description**:

- Daily Operations:_- Subject matter expert for process equipment performance and operation to ensure safety, compliance and sustained operation.- Effectively communicate and collaborate with cross function stakeholders to address operational challenges and concerns to ensure sustained operation and mínimal interruptions to operations activities.- Lead and participate in equipment breakdown investigations to identify root causes. Effectively communicate to the customers on the subsequent plans, short term and long term mitigating actions.- Collaborate closely with cross functional SME to implement effective corrective, preventive action and improvements to eliminate or mitigate future recurrence.- Ensure operation continuity through asset lifecycle management planning, assess and identify impact to safety, compliance, operational schedule and cost.- Perform assessment for equipment during new product introduction, change controls and other qualifications activities to ensure equipment are in its validated state.
- Continuous improvements, Innovation and operational sustainability:_- Participate in related AMGEN network forums to determine innovative opportunities to improve reliability, efficiency, agility and differentiation.- Continuously improve business intelligence capabilities utiliising big data analysis tools to extract, analyze and trend performance data for predictive monitoring and troubleshooting.- Actively seek opportunities for contiuous improvement to improve efficiencies and differentiation through flexible use of new technologies and best industry practices.- Benchmark equipment performance (e.g. reliability, productivity) and determine improvement plans.- Periodically review and/or improve equipment safety, maintenance strategy, spare parts and other continuous improvement opportunities to enhance reliability.- Work independently and/or with project managers to complete engineering projects of various scales within schedule, budget and quality constraints.- Responsible for commissioning and qualification activities including FAT, SAT, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment- Participate in the system walk-down, ensure the closure of punch items and support the takeover of the system from the project team- Lead equipment readiness initiatives for New Product Introduction or Product Campaign Changeover
- Orgainzation Leadership_- Develop the best team by coaching and mentoring engineers to develop their technical competency and leadership skills.- Work in teams by educating customers on lesson learns, collaborate with customers managers to identify knowledge or trainings gaps.- Deliver strong result in the right way by consciously being a role model that ensure results are deliver without compromising on core AMGEN values.
- Qualifications_

Basic Qualifications- Master’s degree in Engineering discipline and 5 years of directly related experience

OR- Bachelor’s degree in Engineering discipline or 8 years of directly related experience

Preferred Qualifications/Competencies:
- Able to work independently with mínimal of no supervision.- Experience in managing various stakeholders expectations related to process equipment in biopharmaceutical.- Good communications skills, both oral and written, including presentation skills. Good interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met.- Strong analytical skills and knowledge of industry trends to identify potential improvement opportunities. Ability to combine technical problem-solving skills with business acumen to determine best business solution.- Working knowledge of biopharmaceutical processes such as inoculation, bioreactors, harvest is preferred. Process knowledge on chromatography, buffer / media tanks, viral filtration, tangential flow filtration, single use technologies and critical utilities will also be considered.- Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation.

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