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As a member of the Technology Projects Team, the role will support complex and challenging system Technology initiatives and project delivery.
Job Responsibility:
Responsible for supporting all tasks related to the technology system project lifecycle, from solution design to GMP qualification
Project management and execution of assigned projects including project prioritisation, resource management, status reporting and external communication
Working with various stakeholders to scope projects and ensure requirements are satisfied
Critically analysing system design, developing, and recommending continuous improvements in line with the latest technology and regulatory standards
Work in a collaborative manner within cross functional teams
Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures
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
Develop detailed specifications, engineering documents, system impact assessments, test protocols and standard operating procedures
Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Travel at various times may be required to support execution of projects
Requirements:
Bachelor’s in electrical engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 5+ years’ experience in operations/manufacturing environment
Manufacturing automation experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities
Excellent control systems automation background focused specifically in design, installation, programming, validation and lifecycle maintenance of automated equipment
Experience programming and troubleshooting PLC (e.g. Allen Bradley, Siemens, B&R), SCADA (e.g. IFix, InTouch, Zenon), PCS (e.g. Rockwell Automation Platforms) and Batch Systems (e.g. Factory Talk Batch)
Industrial Networking experience with ControlNet (CNET), DeviceNet, Profibus etc
Experienced in the use of Automation support tool such as RSLinx, RSNetworx, FactoryTalk AssetCentre, ThinManager and OSIsoft PI Data Historian
Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11
Working knowledge of network architecture technologies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls
Solid leadership, technical writing, and communication/presentation skills
Experience in change control, non-conformance, corrective and preventative actions, and validation practices
Experience in developing technology strategies for new product introduction and new technology deployment
Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
Ability to influence the development of business area strategy and Technology strategy where appropriate
Ensure application of corporate blueprint and standards using business drivers to local business needs and project requirements
Independent, self-motivated, organised and able to multi-task in project environments
Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
Proficient in managing relationships with stakeholders, coordinating and collaborating with teams from different departments in order to achieve common goals