Job description:

Job Summary

Reporting to the AIS Team Lead, this role will be responsible for the successful management and execution of all the AIS activities supporting Quality and Laboratory information systems and will lead the implementation of new Quality and Laboratory information systems.

Essential Duties and Responsibilities

• Act as an Information Systems Analyst supporting Quality and Laboratory information systems.
• Ownership and administration of the IS aspects of Lab equipment – including analytical equipment platform architecture, system ownership and lifecycle management.
• Lead and support system improvements, development of detailed specification and standard operating procedures.
• Lead technical root cause analysis, incident investigations and troubleshooting issues related to the Quality and Laboratory information systems.
• Support new technology introductions by performing IS assessments and implementing IS system configuration changes.
• Solving complex problems, project management, lifecycle management and operational excellence.
• Develop and manage change control requests per established SOPs and processes.
• Support cyber security initiatives – tracking and scheduling the deployment of OS Patches
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• 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

• Ability to master, with minimal support, new IS technologies and processes
• Ability to ensure compliance with practices, policies, procedures, legal requirements and site objectives and goals.
• Technical leadership skills with a strong ability to support continuous improvement initiatives. In addition to leadership capabilities, candidates must have a working knowledge of the GAMP software development lifecycle

Experience

• Minimum of 5 years’ experience supporting Quality and/or Laboratory Information Systems in the biotechnology or pharmaceutical industries or has worked in similar Laboratory environments and has gained expertise in the use of Laboratory information systems.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Experience with Empower CDS, LMES, Sample Manager LIMS, Laboratory Analytical Equipment and instruments will be an advantage.
• Experience of day to day vendor management and contract negotiations with focus on Quality and/or Laboratory information systems suppliers.

Knowledge

• Working knowledge of the GAMP software development lifecycle.
• Strong knowledge of databases, reporting and analytic systems

Qualifications

• B.Eng or B.Sc in Engineering, IT or relevant science discipline is required.

Behavioural Competencies

• 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 client expectations
• Drive a Continuous Improvement Culture within the Engineering team.

WuXi Biologics are an equal opportunities employer.