Senior DeltaV Automation Engineer – Biopharma Drug Substance Manufacturing - (JP15768)

3 Key Consulting•Thousand Oaks, CA

46d•Onsite

About The Position

We are seeking an External Automation Engineer based in Thousand Oaks, California to augment our client’s MCS F&E Automation team. This role will support ongoing biological processes by updating, maintaining, and improving DeltaV automation systems, and providing critical site support. The successful candidate must exhibit sound analytical thinking and problem-solving skills, exemplary communication and collaboration, and operational excellence. A proven ability to work in cross-functional teams is critical for this role. The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making. Strong leadership, technical writing, and communication/presentation skills. Ability to perform independently, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.

Requirements

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
DeltaV Batch Experience
Knowledge of standard biopharma manufacturing processes
Background in design, installation, programming, and validation of automated processes.

Nice To Haves

Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.
Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Clinical and Commercial Drug Substance Plant Operations.
Direct knowledge of Automation design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration, and integrating various OEM automation software.
Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g. cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.
5+ years’ combined experience with the following: Emerson Delta-V DCS system Rockwell Automation SCADA and PLC Platform.
Electronic Batch Reporting Systems Design and implementation experience.
Process Control Network design including network segregation
Process Control Systems: Virtual Infrastructure design and implementation and ability to perform advanced troubleshooting activities with client IS.
System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
Compliance and regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.
Demonstrated understanding of project life cycles is preferred.
Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations.

Responsibilities

Develop and support process control applications via Distributed Control Systems (DCS), Human Machine Interfaces (HMI), Supervisory Control and Data Acquisition systems (SCADA), and Programmable Logic Controllers (PLC).
Collaborate with scientific and operational staff to help translate process requirements into automation and engineering design.
Participate in technical root cause analysis, incident investigations, and troubleshooting on process control issues related to instrumentation and control systems.
Design and test of automated process equipment.
Support new product and technology introductions by performing engineering assessments, implementing automation system configuration changes, and supporting engineering runs.
Support capital projects by applying advanced automation engineering principles in the design, specification, configuration, startup, and commissioning of process equipment and systems for capital projects of significant scope and complexity.
Development of detailed specification, engineering documents, SOPs, and operating standards.