: Automation Engineer - Biotech (JP4914)
:Thousand Oaks, CA
: 12 months with likely extensions
: DSC EFR Automation III
3Key Consulting is looking for an
Engineer for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA.
Ideal Candidate: 2 years experience in biotech industry. Someone already experience in Automation Engineering. Familiar with Emerson DeltaV
Global leader in the Biotechnology industry is seeking a professional Automation Engineer for employment. As a member of the Delivery Supply Chain - Engineering & Facilities Reliability (DSC-E&FR) Automation team, the successful candidate will be required to support complex and challenging system automation initiatives that require solid understanding of analytical problem solving techniques, project management, lifecycle management and Operational Excellence. This position requires an extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
Job Responsibilities include:
1) 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).
2) Lead and support of capital projects. This role involves the application of advanced automation engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations.
3) Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
4) Development of functional specification, detailed specification, engineering documents, SOP and operating standards.
5) Ownership and administration of process control automation in a pre-pivotal phase appropriate and/or cGMP regulated manufacturing setting. Engage in, and process change control requests per established SOP and processes.
6) Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems.
7) Design and testing of newly installed and currently installed automation based process equipment.
8) Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
9) Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
10) Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Master’s degree OR Bachelor’s degree & 2 years of directly related experience OR Associate’s degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience.
1) B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
2) Strong control system automation and bioprocessing background focused specifically in design, installation, programming and validation of automated processes are essential.
3) 2 or more years combined experience with the following product platforms.
a. Emerson DeltaV DCS systems version 12 or above.
b. Rockwell Automation Factory Talk & ControlLogix PLC Platform is a plus.
c. One or more years’ experience leading a team as well as work self-directed.
4) Ability to create, update and read electrical and process design packages including URS, FS, SDS, ICO, ACO, IQ, OQ, CSR and VSR among other engineering and validation documentation.
5) Knowledge of ASTM 2500, S88 and S95 industrial automation standards. Continuous batch processing is a desired advantage.
6) Strong leadership, technical writing, and communication/presentation skills are required.
7) Work schedule flexibility as required to support on-going process operations, requiring occasional after-hours engineering coverage as needed.
8) Collaborate and support development of automation strategies for New Product Introduction and New Technology Deployment.
9) Direct experience in process control engineering and troubleshooting with both stainless steel and single-use unit operations such as bioreactors, harvest, depth filtration, viral inactivation, chromatography, viral filtration, and ultrafiltration/diafiltration.
10) Cleaning systems: CIP’s, COP’s, Glass washers, and Autoclaves.
11) Position requires a working knowledge of manufacturing IT network, data historian, electronic batch records, OPC, Profibus, Ethernet IP, Modbus and DeviceNet technologies.
12) Working knowledge and experience with pre-pivotal phase appropriate and/or 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.
13) 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 Must have Skill Sets
1) Strong control system automation and bioprocessing background focused specifically in design, installation, programming and validation of automated processes are essential. 2) Two or more years experience with Emerson DeltaV DCS systems version 12 or above and one or more years’ experience leading a team as well as work self-directed. 3) Position requires a working knowledge of manufacturing IT network, data historian, electronic batch records, OPC, Profibus, Ethernet IP, Modbus and DeviceNet technologies.
Employee Value Proposition
: Possibility of turning an FTE.
: Must be familiar with biotech processing.
Phone and/or in-person interviews will be accommodated.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
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