Manage the design, implementation, and support for Plant-Wide Process Automation (PA) and Supervisory Control and Data Acquisition (SCADA) solutions within the West Chester, OH facility used to support pharmaceutical development and manufacturing. Manage activities of 3rd Party engineering firms and PA/ SCADA consultants assigned to plant IT projects and deliverables. Responsibilities include reviewing and approving requirements, specifications, drawings, coding procedures, and guidelines; and oversight of implementation, commissioning, and validation of control systems.
- Coordinate with subject matter experts and development partners to align automation projects, resources and support activities with other site organizations and projects including Engineering, Operations, QA Validation, and QA Ops.
- Coordinate project activities with business owners, partners, internal/ external project team members and consultants.
- Consult as subject matter expert on automation systems and processes within functional area.
- Ensure procedures, processes, and SOPs are established and maintained for the design, development, validation, and support of department solutions.
- Ensure solutions are compliant with FDA GxP validation including Part 11 and other regulations where appropriate.
- Work with the process engineering and development groups on developing and maintaining batch process recipes.
- Write, review, and approve SOPs related to SCADA and Process Control systems.
- Train and coach manufacturing employees in the operation of new systems and processes.
- Stay current on industry and FDA process automation. Draft, review, and approve requirement, specs, drawings, coding procedures and guidelines; and oversight of implementation, commissioning, and validation of control systems. Use RSLogix to execute programming changes to Rockwell PLC systems.
- Perform support, change control, and applicable maintenance of all systems.
- Configure Rockwell RSView SE software for HMI graphics and alarm changes.
- Initiate and Maintain Process Control system infrastructure.
- Configure MSSQL process database for additions and improvements at the facility.
- Specify Projects and Systems Supported (including but not limited to): Automated aseptic filling lines; Automated bulk manufacturing lines; Automated utility control systems; Automated HVAC systems; SCADA/ HMI systems and SCADA/ Reporting systems.
- Apply knowledge and support for Good Automated Manufacturing Practices (GAMP5).
- Prepare protocols reports, summary documents, equipment specifications and SOPs.
- BS in Engineering, Computer Science or related area and 6 years relevant industry experience; or MS with 4 years relevant industry experience.
- Minimum 6 years experience within cGMP regulated industry preferably in pharmaceutical/ biotech area.
- Minimum 6 years experience in process automation and/ or engineering.
- Demonstrated project management, engineering, software development, and/or implementation experience for Process Automation and SCADA systems.
- Functional knowledge of Process Automation and SCADA systems and industry best practices.
- Process Automation and SCADA system design, implementation and support experience within a pharmaceutical development and manufacturing environment.
- Experience with validation of automated systems for pharmaceutical process, HVAC and utility controls, including 21CFR part 11 requirements.
- Knowledge of GMP practices, FDA requirements, computer software, and automation validation.
- Knowledge of MSSQL Databases and procedures. PLC programming, Rockwell ControlLogix preferred. Some HMI programming experience, Rockwell RSView preferred.
- Hands-on ability to troubleshoot and install process automation equipment.
- Well-organized and manage multiple assignments at a time.
- Effective written and verbal communication skills and presentation skills.
- Work independently and coordinate activities for various team members and stakeholders.
- Manage multiple tasks and projects simultaneously.
- Self-starter/ self-motivated.
Unimpaired Manual Dexterity.
Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations.
Laboratory, Office, Manufacturing
Up to 20% travel. On-Call support.
Amylin Pharmaceuticals, Inc. - 9 months ago