Job Description

Job Description

We are seeking a Process Engineer I to support our commercial biotechnology facility in El Segundo. Under minimal supervision, this position’s main accountabilities are focused on the front line technical support of the Cell Therapy process. Under general supervision, this position’s main accountabilities are focused on the frontline support of manufacturing operations , equipment implementation, APVs, risk assessments, change control, CAPAs and process improvements.

Responsibilities include, but are not limited to:

Provides front line technical support for manufacturing of cell therapy products

Ensures successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment, process issues

Partners with MSAT Team to execute process development studies within commercial facility to further develop a thorough understanding of operating and performance parameters

Represents technical Operations in Change Control, CAPA and Deviation meetings

In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools

Devises and implements CAPAs to address root cause and ensure effectiveness

Initiates deviations and Change controls

Collaborates with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents

Implements continuous design/process changes (low to mediun in complexity) that are required by the Business as a result of Change controls, CAPAs, Enhancements.

Develops Work Instructions and SOPs to support the Process

Point of contact for help and mentoring to business users of the process

Develops training material and implements process changes and creation of SOPs

Identifies additional training or self-help improvement needs and communicates recommendations

Performs OQ/ PQ testings

Reviews URS/ OP/PQ protocols

Impact Assessor for proposed and upcoming changes in the process/system

Participates in the implementation of different Projects

Participates in internal audit/inspection

Other tasks and duties as assigned by Management

Basic Qualifications:

MA/MS Degree in Biochemical Engineering or Chemical Engineering

Bachelor’s Degree in Biochemical Engineering, Chemical Engineering, Biotechnology with 2+ years of experience Or

AA Degree with 4+ years of experience in Biochemical Engineering or Chemical Engineering Or

High School Degree with 5+ years of experience in Biochemical Engineering or Chemical Engineering

Preferred Qualifications:

Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions

Cell Therapy CAR-T process Knowledge

1+ years of experience with current Good Manufacturing Practice (cGMP) Regulations

1+ years of experience with MES

Possesses good communication skills

The salary range for this position is: $81,940.00 - $106,040.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

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