Role Summary
Senior Automation Systems Integration Engineer responsible for designing, implementing, and supporting data acquisition and analysis systems. Work involves real-time data collection and analysis, integrating software and hardware for automated equipment, and ensuring compliance with change control and GAMP 5 guidelines. Collaborate with a diverse team of engineers, developers, analysts, and administrators to optimize manufacturing processes.
Responsibilities
- Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures.
- Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automated control systems.
- Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5 guidelines.
- Supporting small manufacturing, engineering, and validation projects.
- Providing support to process control and process monitoring equipment software design, commissioning, testing, and corrective action.
- Authoring or updating system specifications, user and functional requirements specifications, generating and executing FAT and SAT protocols.
- Reviewing cyber security vulnerabilities and risk pertaining to automation systems, software, and infrastructure.
- Creation, modification, and maintenance of automation system documentation.
Skills
- Experience with OT applications, including SCADAs, HMIs, Historians, etc.
- Familiarity with standing up large systems at the enterprise level
- Core knowledge of ISE S95 and S88 principles and IT/Automation integration
- Familiarity with PLC communication, HMIs, computerized system design and maintenance of automation process control infrastructure
- Commitment to continuous improvement and project-oriented work
- Aim to be regarded as an expert in keeping biopharmaceutical processes running smoothly
- Ability to balance changing priorities with increasing workload and communicate timely decisions
Qualifications
- Bachelor's Degree in Computer Science, Chemical, Mechanical, or Electrical Engineering
- Senior Engineer: 5+ years of relevant experience
- Principal Engineer: 8+ years of relevant experience
- Level will be determined based on qualifications relevant to the role
Education
- Bachelor's Degree in Computer Science, Chemical, Mechanical, or Electrical Engineering
Additional Requirements
- On-site work may be required in certain locations; discuss policy with recruiter/hiring manager