Sr Engineer - Software

Advanced Bio-Logic Solutions Corp; Thousand Oaks (CA); On-site; Full time

Job summary

A leading biotech engineering company is seeking a skilled Process Control Engineer for their Thousand Oaks facility. The ideal candidate will have extensive experience in automation system development and a strong background in regulatory environments, focusing on improvement of process equipment and utilities. This highly collaborative role requires both technical proficiency and leadership skills in a GMP-regulated atmosphere.

Qualifications

• 5+ years of experience with Rockwell Automation and Allen-Bradley PLCs.
• Experience in regulated environments with cGMP understanding.
• Familiarity with batch control systems and engineering documentation.

Responsibilities

• Develop process control applications using PLC, DCS, HMI, and SCADA.
• Support integration of new drug manufacturing technologies.
• Lead troubleshooting and root cause analysis on automation issues.

Skills

Automation

Control Systems

Technical Writing

Communication

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Rockwell Automation

ControlLogix

Factory Talk

cGMP documentation

PLC

Job description

Description:

Exact Schedule - fully onsite(Thousand Oaks, CA ) 8am-5pm M-F, OT possible

Job Responsibilities include:

• 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

Basic Qualifications
Doctorate degree OR - Master’s degree & 2 years of directly related experience OR - Bachelor’s degree & 4 years of directly related experience OR - Associate’s degree & 8 years of directly related experience OR – High school diploma / GED & 10 years of directly related experience

Preferred Qualifications

• 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:
• Lyophilizer System, Filling systems for Syringe and Vials and Building Management System
• Testing and Inspection machines for devices
• Clean Utilities (WFI Still A\B, Clean Steam Generator, Chemical Dist. System, WFI Storage & Distribution and Purification System)
• 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.

Top 3 Must Have Skill Sets:

• 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.

Pay Rate between $68 - $78/hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"