Job Number: 20-06868
Job Number: 20-06868
Be a part of a company that supports life-changing healthcare solutions. Eclaro is looking for an Automation Engineer for our client in Carlsbad, CA.
Eclaro’s client is a leading manufacturer of lab materials, technology and service supporting the Life Science field. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Client is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications.
- Our Automation Engineer's primary responsibility is to provide automation support to the Client’s Operations as part of the Process Automation group, focused on the PCS (Process Control System) to implement continuous improvement changes, support MAR (Make Assess Release) activities, and lead and / or assist with expense / capital projects.
- Constantly required to sit and reach to use computers and other office/lab equipment
- Constantly required to view objects at close and distant ranges
- Frequently required to communicate with others
- Employee frequently will work in an office environment and production area with computer equipment, machinery, tools, and moderate amounts of noise and activity.
- Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials.
- The work environment is fast-paced and demanding.
- This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment.
- Employee will conduct off- shift, weekend, and overtime duties as assigned by the manager of the employee.
- BS Degree in Chemical, Electrical Engineering, Mechatronic Engineering, Mechanical Engineering, or Computer Science or equivalent training and experience.
- Minimum of 5 years in the design, implementation and/or support of instrumentation and control systems, preferably in the Bio-Pharmaceutical, Pharmaceutical, food or other batch processing industries.
- Working experience with Distributed Control Systems (DCS), Manufacturing Execution Systems (MES), software development methodologies and automated systems life cycle support in a regulated industry.
- Systematic knowledge of Automation Society (ISA) Standards S88 and S95 as well as the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP) Guide to the Validation of Automated Systems.
- Thorough understanding of cGMPs (current Good Manufacturing Practices), particularly as they relate to the operation, validation and maintenance of computer-controlled systems. And Code of Federal Regulations (CFR). Part 11.
- Comprehensive understanding of engineering techniques and principles and the ability to apply that knowledge as required.
- Thorough knowledge of Piping & Instrumentation Diagrams (P&IDs), I&E (Instrumentation and Electrical), such as networking, architecture (including panels), IO / device configuration, and wiring diagrams.
- Work with Manufacturing, Quality, F&E (Facilities and Engineering), Process Engineering and Science and Technology departments to implement corrective actions and continuous improvement changes, and lead/support expense /capital projects.
- Develop, review, and approve applicable automation-related specifications and any other related documentation.
- Perform off-line and on-line configuration, testing, and peer reviewing, and procedures related to software configuration management in multiple environments.
- Support design, development and execution of Automation Change Records and qualification/commissioning test documentation.
- Perform troubleshooting of process, equipment, and system malfunctions or failures involving the PCS (Process Control System)
- Perform quality discrepancy evaluations/assessments and provide support for investigations.
- Assist with equipment testing and debug activities.
- Review and assess change records, risk assessments, and user requirements.
- Represent automation engineering on multidisciplinary and cross-functional project teams.
- Perform cGMP reviews of executed Automation Work Plans and tests for completeness and accuracy.
- Support validation protocols related to automation.
- Preferred Qualifications:
- Knowledge of Rockwell, Emerson Syncade & DeltaV architecture, software programming, and communication protocols is preferred.
- Knowledge of scripting as it relates to automation-based DCS databases / software applications is a plus.
- Certifications such as CAP, P.E., PMP preferred but not required.
- Project management experience is a plus.
- Mentor incoming automation engineers, consultants, interns or rotational personnel
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Maria Castañeda | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.