The Position

Our Oceanside facility is a multi-product CHO drug substance manufacturing site with parallel commercial production and launch capabilities. One of the Facilities & Engineering key capabilities is to be the turn key frontline equipment support organization for Manufacturing Operations, ensuring zero business disruptions. In this role you will be responsible for providing technical expertise to support Manufacturing support equipment systems (e.g. CIP skids, washers and autoclaves) are fit for purpose and ready to use. Knowledge and experience working under GMPs and validation requirements is essential. Responsibilities may include subject matter expertise and oversight ensuring reliable system performance, investigating major equipment events, and transferring new processes into the facility.

Job Responsibilities:

• Ability to lead and direct projects

• GMP understanding and good documentation skills are must have

• Understanding of Quality systems and Validation systems such as Veeva and eValRoche

• Familiarity with MES (Syncade), DeltaV, and CMMS/CCMS (SAP, BM RAM)

• Familiarity with PLCs (local/skid controls) and SCADA system

• Knowledge of PID control theories and techniques

Manufacturing Support

• Provide equipment related technical support to manufacturing, including third line on-call support, with first line as manufacturing and second line as Process Maintenance or Instrumentation Services Group

• Responds to support requests, troubleshoots issues, and identifies corrective actions

• Perform product quality impact assessments as needed

• Provide technical assessments for investigations, validation and change control as needed

Equipment

• Investigate events using formal problem solving tools to determine root causes

• Monitor operations, equipment performance, and analyze data

• Recommend equipment improvements using data and decision making tools

• Responsible for equipment maintenance, calibration and spare parts strategies

• Assist in ensuring master data for assets is accurate

• Ability to provide recommendations and implementation of new equipment from both the site and network perspective

Projects

• Develop initial scope of work and estimates for new projects

• Lead and execute small equipment projects

• Contribute to the project scope, schedule, and requirements for larger projects

• Develop the creation of User Requirements Specifications (URS)

• Participate/Lead design review meetings

• Review/update process description and parameters list

• Supports the startup, commissioning, and qualification of new equipment

• Attend fabrication, factory acceptance testing, site installation, site acceptance testing as needed

Required Skills & Experience:

• Bachelor Degree in Engineering required with focus on Chemical, Mechanical, Electrical or Computer Science preferred

• 4+ years’ applicable automation, instrumentation and control system, or and/or electrical experience is required

• 1+ years’ work experience in a pharmaceutical/ biotech industry/ GMP experience is required

• Thorough knowledge of process, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation

• Thorough knowledge of cGMP guidelines, experience in generation of controlled documents and extensive experience in equipment start-up and validation

• Ability to generate engineering drawings and specifications

• Requires use of a wide variety of technical skills to solve multiple disciplinary complex engineering challenges. Will encounter diverse or difficult characteristics in engineering principles and concepts

• Demonstrated ability to work as part of a multidisciplinary team

• Ability to work with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines

• Demonstrated technical proficiency, leadership, creativity, and strategic thinking

• Excellent communication, interpersonal, organizational and project management skills

Work Environment/Physical Demands/Safety Considerations:

• Work in standard office/remote environment

• May work in the clean room environment that requires gowning be worn in the form of hospital scrubs, bunny suits, gloves and steel toe boots. Also, no makeup or jewelry can be worn when working in the clean room environment

• May work with hazardous materials and chemicals

Relocation assistance may be considered for this role.
Job descriptions are not intended, and should not be construed, to be all-inclusive lists of all responsibilities, skills, efforts, or working conditions associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add, or remove duties and to assign other duties as necessary.

The expected salary range for this position based on the primary location of Oceanside CA is $68,000-$126,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the
benefits detailed at the link provided below.
Benefits
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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.