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Sr. Automation Engineer

4 months ago

San Diego, California, United States Pacira Biosciences Inc. Full time

Summary:This position assumes responsibility as the technical owner of various commercial manufacturing and supporting control systems and applies available resources to manage them. This position will maintain existing control systems and plan and execute automation/controls projects from concept to final closeout in support of site objectives.Essential Duties & Responsibilities:The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.Troubleshoot and diagnose complex control system problems, working closely with Metrology, Facilities, MS&T, and other teams.Ensure business continuity thru appropriate maintenance of control systems and software as the automation technical lead supporting commercial manufacturing.Provide on-call support for commercial manufacturing on a rotating basis with other team members.Engineer and manage medium to large process control system/equipment improvements, expansions, and upgrade projects to meet site objectives.Provide moderate to advanced technical assistance to site operating groups through investigations, control system risk assessments, and design support.Apply cGMP principles within the workplace. Incorporate cGMP and regulatory compliance into all assigned project scopes, design, and construction activities.Work closely with IT infrastructure and support groups as a cross-functional team member to meet automation project objectives.Assist in preparation and execution of the validation qualification protocols related to automation software and control systems.Provide technical and non-technical feedback to validation personnel for the successful qualification of systems.Update, develop, and maintain user requirement specifications, functional specifications, design specifications, and operation and maintenance procedures for new and existing control systems.Contribute to quality event (QE) investigations and corrections.Supervisory Responsibilities:This position has no direct reports.Interaction:The incumbent works closely with all functional areas related to and supporting commercial manufacturing.Education and Experience:Bachelor's degree in Electrical/Controls or Mechanical Engineering (BSEE or BSME) or other relevant field required8 years of relevant experience required5 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment preferredWonderware and Siemens Apogee BMS experience preferred. Hands on experience with Windows Servers hardware and Microsoft Windows - applicationsExtensive cross-functional team experience, including technical and non-technical work Recognized as a technical expert by peers and other personnel within the business unitSuccessful track record of managing wide-ranging activities within the business unitDemonstrates independent project management skills to successfully deliver automation projects to completion.Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Knowledge, Skills, and Abilities:The position will require up to 15% travel for equipment and software FATs, system evaluations, conferences, and technical training.This position requires a high degree of analytical skills and knowledge of automation engineering solutions to improve processes and integrate new equipment to meet company and project objectives.Ability to perform automation engineering tasks and implementations under limited supervision.Possesses a high level of technical expertise of process control systems, facility equipment and systems that support manufacturing production, process instrumentation, PID control loops, and related electrical and electronic equipment.Hands-on experience with Allen-Bradley PLCs, VFDs, Rockwell programming software, AVEVA (Wonderware) System Platform, Siemens Desigo, and various types of server-based software.Ability to organize and present technical topics and project overviews.Maintains up-to-date technical knowledge and skillsets. Shows initiative by developing new methodologies or technologies for process control systems.Physical Demands:While performing the duties of this job, the employee is frequently required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 40 pounds.Work Environment:Typical office setting with laboratories, office areas, and cubiclesManufacturing clean rooms and gowningEquipment/utility areas