Job Description

The Sr Automation Engineer is responsible for providing day-to-day automation engineering
support in Bulk Drug Substance, Fill and Finish operations (Bioreactors, Chromatography
skids, Ultrafiltration skids, CIP skids, Media and Buffer Preparations, CIP/SIP processes,
Lyophilizers, Filling machines) including execution of automation projects of varying
complexities.

Essential Duties and Responsibilities

Demonstrate solid understanding of programming, troubleshooting, maintenance, and
user administration of the various automation platforms used at the Thousand Oaks site
including, but not limited to, Emerson DeltaV DCS, Allen Bradley PLC, Siemens PLC,
Intellution/Proficy iFix, Siemens BAS, and Siemens S7.
Develop improved and robust control system strategies for manufacturing processes.
Draft, update, and routinely verify system specifications and standard operating
procedures (SOP) for the automation systems supported.
Execute and adhere to pharmaceutical change control standards and policies.
Train users on control system functionality (process control, computer/control networks,
and instrumentation).
Work with multiple customers manufacturing, maintenance, engineering, quality,
validation, etc. Understand the needs of each and prioritize solutions.
Investigate, analyze, and resolve automation system problems in a high-pressure
environment.
Performs user interventions (UI) to ensure that the manufacturing process maintains a
continuous flow. Implement sustainable and timely system changes to reduce UI
occurrence/recurrence, addressing root causes.
Administer all aspects of the control system life cycle in a regulated environment. Keep
all software and documentation up-to-date and in a state of compliance.
Participate in the execution and ownership of Project Records (PR) for DeltaV/PLC/iFix
SCADA/BAS/BMS software and hardware changes.
Draft and execute functional tests, Commissioning Plans, and Qualification Protocols.
Own and close corrective actions related to the automation system; including, but not
limited to, Corrective Action & Preventative Actions (CAPA) that are generated due to
user interventions and/or non-conformances/events.
With minimal guidance, schedule and lead a team through the planning and execution of
automation projects, or a defined piece of a larger project. This includes generating
detailed, accurate project schedules and cost estimates, preparing business case
justifications, interfacing with cross-functional development groups and technical
support groups.
Manage routine small projects with complex features without assistance.
As a Subject Matter Expert (SME), lead, train, and mentor other automation engineers
and/or technicians as requested in automation systems.
Required to participate in a rotational 24/7 automation on-call support.
May perform other duties as assigned.

Qualifications

Able to prioritize multiple tasks from multiple customers.
Able to elevate issues up to a higher authority when needed.
Able to discuss encountered technical issues, verbally and in written form.
Excellent communication skillset is a must and ability to work as a collaborative team
member.
Demonstrated ability to solve routine design, process, and automation engineering
problems without assistance.
Able to effectively lead and train less experienced engineers. Effectively operate and
potentially facilitate cross functional teams with minimal guidance.
Able to effectively run projects, coordinate contractors, and direct the activities of
technicians.
Able to use experience and judgment to plan and accomplish goals with minimal
supervision.
Organize and present technical and project management overviews without assistance.

Education and/or experience

Bachelor\'s degree in engineering field is required.
Minimum of 3 years of DeltaV automation/controls experience in a GMP pharmaceutical
environment is required.
Knowledge of the basic principles in various engineering disciplines.
Solid experience with automation system instrumentation and field device technology.
Experience with Emerson DeltaV Distributed Control System (DCS), operation,
infrastructure, and configuration (batch and continuous control) required.
Familiarity with Werum PAS-X, Allen Bradley, Intellution/iFix, Siemens BAS, Siemens
PCS7, WinCC, Modicon PLC, Wonderware (HMI and Batch), is a plus.
Knowledge of cGxP Bulk Drug Substance unit operations: Bioreactors, Chromatography
skids, Ultrafiltration skids, CIP skids, Media and Buffer Preparations as well as CIP/SIP
processes; Fill and Finish experience is a plus.
Knowledge of control system lifecycle management in a regulated environment is a plus

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