3 Key Consulting, Inc. ยท 5 months ago
Automation Senior Software Engineer, Biotech, DSC, SCADA HMI, PLC - (JP14368)
Thousand Oaks, CA
Full-time
Onsite
Senior Level
$60/hr - $80/hr
5+ years exp3 Key Consulting, Inc. is hiring a Senior Engineer for a consulting engagement with a leading global biopharmaceutical company. The role involves developing process control applications, supporting projects for manufacturing technologies, and ensuring compliance with industry standards in a GMP regulated environment.
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Responsibilities
Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA)
Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility
Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP
Development of detailed specification, engineering documents, SOP and computerized system administration job plans. Testing of automation-based process equipment
Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in process change control requests per established SOP and processes
Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation and control systems
Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs
Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Qualification
Required
5+ years of experience working on Rockwell Automation and Allen-Bradley PLCs (Factory Talk & ControlLogix)
Experience with Process Design, Commissioning and change control methodology
Direct experience with regulated environments including detailed understanding of cGMPs
Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA)
Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility
Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP
Development of detailed specification, engineering documents, SOP and computerized system administration job plans
Testing of automation-based process equipment
Ownership and administration of process control automation in a GMP regulated manufacturing setting
Engage in process change control requests per established SOP and processes
Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation and control systems
Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs
Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Preferred
B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering
Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential
5 or more years combined experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform
Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation
Knowledge of S88 and S95 techniques. - Batch processing a desired advantage
Strong leadership, technical writing, and communication/presentation skills are required
Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage
Experience in developing automation strategies for New Product Introduction and New Technology Deployment
Preferred Experience using the following systems: a. Lyophilizer System, Filling systems for Syringe and Vials and Building Management System b. Testing and Inspection machines for devices c. Clean Utilities (WFI Still A/B, Clean Steam Generator, Chemical Dist. System, WFI Storage & Distribution and Purification System) d. Cleaning Systems (Autoclaves, Depyro oven, COPs and Glass Washers, Pressure Vessel Washer, Vial Washer and Ultrasonic Washer)
Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Profibus, Ethernet/IP and DeviceNet technologies
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment
Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices
Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
Benefits
Benefits
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
Company data provided by crunchbase