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 GAMP 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
Required Experience:
Senior IC
A leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing