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Biomedical Engineer

4 months ago

Thousand Oaks, United States EPITEC Full time

Overview:

Our Automation team is seeking experienced Automation Engineers to contribute to Clinical & Commercial Plant Automation programs and Capital projects. This role requires a strong background in Life Sciences, specifically Biotechnology and Biomedical Engineering, coupled with expertise in Emerson Delta-V DCS Programming, Rockwell Automation SCADA and PLC systems, and compliance with regulatory standards like 21 CFR Part 11. The ideal candidate will hold a minimum of a Bachelor's Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or a related life science engineering field.

Job Responsibilities: Collaborate with key stakeholders to develop project plans, business cases, and cost estimates. Work with Operations Information Systems (OIS) to estimate resources and manhours using Manufacturing Information and Technology System (MITS). Participate in detailed design, scope, and schedule preparation and implementation. Implement new automation solutions including DCS, PLC, HMI, and SCADA systems across various projects. Provide post-implementation support including hyper-care, training, SOP revisions, and spare parts management. Ensure compliance with company's Engineering and Operational standards throughout project lifecycle. Support process improvement projects and large capital projects integrating new manufacturing technologies. Assist in new product introductions (NPI) or new technology introductions through automation engineering assessments and configuration changes.

Day-to-Day Tasks: Manage day-to-day support of Drug Substance operations. Maintain a safe working environment in adherence to environmental health and safety regulations. Availability for up to 10% domestic/international travel as required.

Preferred Qualifications: Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering. Experience in capital project lifecycle management, specifically related to Plant Automation and process control systems within GMP biopharmaceutical production facilities. Proficiency with Emerson Delta-V DCS, Rockwell Automation SCADA and PLC Platform, and electronic batch reporting systems. Knowledge of process control network design, system integration, and regulatory compliance (e.g., 21 CFR Part 11, ASTM 2500, S88, S95, GAMP).

Preferred Competencies: Strong project management skills. Ability to influence and motivate cross-functional teams. Effective communicator with excellent meeting management skills. Proactive and results-oriented with strong problem-solving abilities. Demonstrates willingness to go the extra mile to achieve project goals.

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