Applications Automation Engineer
Marin Metro Area, CA
- Support the existing PI Historian infrastructure utilized for manufacturing along with supporting the design, engineering, and commissioning of data collection for new manufacturing equipment.
- Support manufacturing, utilities, and laboratory users by assessing their needs for the PI Historian, and execute independent projects to meet those needs.
- Create a line of communication with vendors to troubleshoot and problems solve issues within the PI Historian environment.
- Investigate and diagnose technical issues and provide recommendations/solutions for corrective and preventative actions.
- Contribute to batch reporting projects/assignments in the support of site operations through requirements gathering, design support, report technical implementation, and test execution. Proactively look for and recommend improvements in site processes and procedures.
- Develop and deploy analytics to aid in batch context generation and production lot review.
- Create, edit, and review appropriate design documentation (User Requirements, Functional Specifications, Software Design Specifications, Configuration Specifications, IQ/OQ).
- Manage requirements and run test scripts for system IQ/OQ in HP Quality Center.
- Support and/or execute acceptance testing and IOQ protocols.
- Follow established Quality Control systems and interface with the QA Validation group for GMP systems.
- 0-3 years of experience in PI Historian, or other database use.
- Experience with PI Asset Framework a plus.
- 0-3 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment.
- 0-3 years of experience with the installation, startup, and servicing of process control systems.
- Experience with PLC and data acquisition systems, and process control systems a plus.
- Experience with developing GAMP documentation for internal projects as well as reviewing/approving vendor supplied documentation (User Requirements, Functional Specifications, Software Design Specifications, and Software Test Plans).
- Experience with networks and communication protocols (e.g. OPC DA, OPC AE, MODBUS etc.) preferred.
- Virtual Machines experience preferred.
- Prior experience with controls systems supplied with skidded equipment utilized in fermentation, cell separation and recovery, filtration, CIP, and clean utilities strongly preferred.
- Proficiency with standard Office software applications, including MS Word, MS Excel, MS Power Point, and MS Visio.
- Familiarity with HP Quality Center and/or Trackwise a plus.
- Strong organization, interpersonal, oral and written communication skills.
- Ability to self-direct and work both independently and in conjunction with cross-functional teams.