KEY RESPONSIBILITIES:
- Responsible for completing scheduled administrative tasks on Manufacturing Equipment and Applications including MES/ MCS / OSI PI and Serialized platforms
- Provide technical support for control systems, MES/ MCS/ OSI PI and Serialization platforms to Engineering, Validation, Maintenance and Process Engineers across Manufacturing and Process Development as required
- Proactively identify opportunities, anticipates problems, and implement solutions with the Process Automation Engineers, Process Engineers, Manufacturing Associates, and the Maintenance team as required for business impacting issues
- Records and investigates issues, performs root cause analysis, escalates to management and other teams as required. Co-ordinates the response with external vendors for issue resolution, upgrades etc.
- Assist in co-ordination and management of manufacturing system related projects works with vendors, engineering project managers and business users to maintain systems to the required standards
- Liaise and communicate with site users and vendors to ensure manufacturing systems operate to maximum effect, and as per the IT Strategy
- Apply knowledge and support for 21CFR part 11 and Good Manufacturing Practices
- Maintain specifications, protocols, procedures, and other documentation as required. Keep documentation current as per site good documentation and data integrity practices (drawings, specifications, validation documentation etc)
- Perform support (with some after hour on-call), change control, and applicable maintenance of above systems
- Demonstrates the ability to operate in a culture of efficiency, helpfulness, innovation, continuous improvement, enthusiasm, reliable & consistent delivery, integrity, partnership, and collaboration, locally and globally
- Act as an agent for process optimisation to reduce downtime
- Act as an agent in the adherence, adaptions and development of IT standards.
REQUIREMENTS:
Qualifications for Candidates
- Bachelor’s degree preferred (Engineering or Computer Science), or degree in process, with experience on manufacturing systems, IT standards and Data management and acquisition
- Basic understanding and experience with automated manufacturing systems.
- Demonstrated track record of administration and support of manufacturing platforms
- Previous experience in the biotechnology / pharmaceutical industries and GXP Computerized Systems
Knowledge/Skills Needed:
- Experience with regulatory governance to ensure business solutions are compliant with cGMP and other regulations where appropriate
- Motivated to provide positive results and to excel
- Ability to understand technical details of manufacturing and development systems
- Excellent verbal and written communication skills, including the ability to explain technical concepts and technologies to peers and management outside of IT
- Ability to operate independently or as part of a global team in an effective respectful manner
Knowledge/Skills what would be of benefit in role
- Experience with OSI PI Historian or similar data historian a plus
- Experience with serialisation systems and associated vision systems a plus Fosters collaborative relationships within and across groups and uses effective influencing and negotiation skills with senior level management and key stakeholders
- Excellent analytical problem solver
- Experience in the use of Seavision Serialization platform
- Experience in the use of PAS-x the Werum eBR platform
- Knowledge in Triaging of support call and ticket management
- Experience with full software development life cycle in regulated environment (FDA, GxP, HIPAA, SOX, GDPR and other data privacy, computer system validation, a plus)
- PLC and HMI SCADA experience a plus based on Siemens and Allen Bradley platform
