Job description:
As a member of the Operations AIS team, the individual will act as an Automation Engineer for VPE systems and will support complex and challenging initiatives, develop automation strategies and support new technology deployment.
Essential Duties and Responsibilities
* Strong experience with vendor packaged automation equipment – PLC/SCADA platforms
* Ownership and administration of equipment control systems in a GMP regulated manufacturing setting
* Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures
* Lead technical root cause analysis, incident investigations and troubleshooting issues related to electrical, instrumentation and equipment control systems
* Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs
* Solving complex problems, lifecycle management and operational excellence
* Develop and manage change control requests per established SOPs and processes
* Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
* System owner responsibilities such as change control, maintenance, backup/restore and disaster recovery and regulatory compliance.
* Perform all duties in accordance with GMP requirements, SOPs and controlled documents
* Flexibility to take on additional tasks and responsibilities at the discretion of the AIS Team Lead.
* Will act as a role model for the Engineering function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
Person Specification
Technical Competencies
* Excellent control systems automation background focused specifically in design, installation, programming, validation and lifecycle maintenance of automated equipment.
* Ensure application of corporate blueprint and standards using business drivers to local business needs and project requirements
Experience
* Manufacturing automation experience in biopharmaceutical or Active Pharmaceutical Ingredient (API) facilities
* Experience in PLC programming and troubleshooting, SCADA Systems, Profibus networking and OSIsoft PI Data Historian – Siemens PLCs / SCADA and HMIs a strong advantage
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices
* Experience in developing automation strategies for new product introduction and new technology deployment
Knowledge
* Knowledge of GMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and 21 CFR Part 11
* Strong network architecture or engineering proficiencies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls
Qualifications
* Bachelors in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 5+ years experience in operations/manufacturing environment
Behavioural Competencies
* Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
* Excellent communication, interpersonal and presentation skills.
* Collaborative and inclusive approach to work and your colleagues.
* Excellent problem solving and troubleshooting skills.
* Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
* Engage cross functionally in conjunction with a site-based team.
* Autonomous and a self-starter who will use their initiative to drive actions forward.
* Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers' expectations