System Owner

Job Function: System Owner
Job Location: Puerto Rico - East Region
Job Posted: April 7, 2021

PACIV, a global leader in industrial automation solutions servicing the Life Sciences sector, is looking for a System Owner for its Puerto Rico office. This position will be located on the Puerto Rico – East Region.

Job Description:

The Process Control System Owner (also referred to as System Owner) is the individual responsible for the overall procurement, development, integration, modification, operation, maintenance, and retirement of a control or information system. The System Owner is a key contributor in developing system design specifications to ensure the security and user operational needs are documented, tested, and implemented.

Position Responsibilities/Essential Functions:

  • Identify and document the appropriate level of control required.
  • Identify and document the protection for data, including use of encryption. Specify data and information classification, criticality, and security requirements by system type.
  • Develop (or adhere to) hardware, network, and application software requirements.
  • Maintain requirements and documentation for the life cycle of the system.
  • Develop (or adhere to) application software, hardware, and security administration change management procedures to ensure that security policies and controls remain effective and that the system is maintained in a qualified or validated state.
  • Demonstrate a general knowledge of role responsibilities and rights and privileges required to perform user roles.
  • Demonstrate a functional knowledge of configuration management and control methodologies and procedures
  • Provide input on training content for system users and administrators.
  • System Owner ensures that the appropriate persons involved in the validation process have reviewed the pertinent documents and that the plans are adequate to properly validate the computer system.
  • Provide specialized knowledge in DCS or PLC Automated System Installation and Integration for pharmaceutical and medical device manufacturing processes and related products.
  • Oversee and in some facilities design, install, integrate, commission and start up, DCS or PLC control systems.
  • Develop, review or approve validation documentation such as user requirements, system designs, system drawings and Standard Operational Procedures, as part of the Control System Lifecycle.
  • Interface effectively with client representative, client’s vendors and PACIV team members.
  • Provide oversight and technical decision-making regarding integration/installation issues for projects and systems in their operation and maintenance phases.
  • Prepare and present technical investigative reports to multi-disciplined management, as required.
  • Formulate recommendations for validation dispositions or other actions related to investigations associated with the control systems.
  • Ensure quality is maintained throughout the life cycle of the system.
  • In some cases, manage automation projects, including supervising craft labor.

Qualifications:

  • Must have 8 or more years of experience with the integration and installation DCS or PLC systems, preferably gained in the pharmaceutical industry.
  • Strong knowledge of system development life cycle.
  • Have strong project management skills in automation projects.
  • Understanding of project budget management.
  • Experience in developing requirements definition, system designs, system drawings and Standard Operational Procedures.
  • Ability to lead automation projects from start to finish.
  • Ability to develop automation schedules and experience with reviewing client’s project schedules.
  • Understanding of regulatory, environmental, GMP and OSHA regulations
  • Experience with word processing, excel and project management tools.
  • Experience with document management system usage.
  • Familiar with construction techniques and installation best practices.
  • Familiarity and understanding of manufacturing methods related to the production of medical device products or pharmaceuticals is required.

Education:

B.S. degree in a engineering discipline such as Mechanical, Electrical or Chemical Engineering.

Please Apply Here: https://paciv.applytojob.com/

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