GMP - (JP15196)

3 Key Consulting•Thousand Oaks, CA

7d•Onsite

About The Position

3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. 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.

Requirements

Working knowledge of Delta V, Rockwell PLCs, automation comm protocols.
Working experience with GMP manufacturing.
Strong communication/collaboration skills with broad audience.
Pharma experience and or Chemical Engineering knowledge – preferred.
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 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.
Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
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.

Nice To Haves

Supplement additional workload on team.

Responsibilities

Develop and maintain process control automation solutions utilizing DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
Lead and support functional area projects focused on improving process equipment/utilities/facilities -to- large/sophisticated capital projects to integrate new drug substance manufacturing technologies into clinical/commercial facility.
Lead/support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.
Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.
Lead and Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call: Day to Day Operational Support, Troubleshooting Support to Mfg. Operations, Automation System Administration, Automation System Operating Systems (OS) and HotFix assessments and rollout, Daily manufacturing and engineering work center team meetings, Preventative and corrective maintenance, Automation System spare parts management, Purposeful Presence on the Floor (PPoF).
Provide Continuous Improvement initiatives including Safety, Productivity and Reliability Improvements.
Automation Business Process Improvements including departmental Standard Operating Procedures (SOP).
Maintain Data Integrity Assessments with the current company and Industry standards.
Collaborate with Drug Substance Plant network to enhance the automation design for Drug Substance Plant Operations.