- This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
- There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives.
- Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
- Support and maintenance of all IT aspects of Laboratory and BTS systems.
- Respond to and troubleshoot IT issues associated with instruments, servers, workstations, networks etc.
- Collaborate with the business and vendors to resolve technical IT software and hardware problems as required.
- Execute routine system administration and maintenance activities as required (Including system audit trail review, system patching, back-up and restore and system recertification)
- Record all incidents, support issues and changes using the SNOW tool.
- Perform and Support IT technical Qualification and Validation activities as led by the business in conjunction with the validation and quality teams.
- Ensure that all IT aspects of BTS systems are kept in a compliant state, and that all maintenance and system enhancement activities are carried out in a compliant manner in accordance with policies and procedures.
- Support and manage the implementation of Business Technology Solution (BTS) projects
- Create and maintain system documentation including procedures, work instructions system design specifications, user requirements, functional requirements, or routine controlled application change forms.
- Develop/Modify/Update SOPs, Work Instructions and Business Process and data flows for each system, and its interfaces.
- Acting as key point of contact for internal and external customers to lead BTS projects through to completion.
- Identify, evaluate and implement opportunities for improvement in current BTS systems and processes.
- Will need to cross-qualify and take backup responsibility within the team for manufacturing IT scope
- Ensure Laboratory & BTS systems compliance with security and data integrity policies and regulatory requirements.
- Adheres to and supports all EHS & E standards, procedures and policies .
- Bachelors or Master's Degree in Engineering, Information Systems, Computer Science or comparable qualification through practical experience in the lab IT field
- At least 5 years' experience providing hands-on IT systems support in the biotechnology or pharmaceutical industries.
- Experience of working with Windows Operating systems, Active Directory, Anti-Virus, TCP/IP, DNS, DHCP, networking protocols, and databases.
- Ability to work independently with minimum direct supervision.
- Experience of Pharmaceutical Industry Regulations cGMP/cGLP, 21 CFR 11 and EU Annex 11 compliance requirements.
- Experience working with all disciplines in and supporting a Laboratory environment including QA, CSV, QC, Lab Analysts.
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Lab & Mfg Systems Engineer - Sligo, Ireland - TEAM HORIZON
Description
Team Horizon is seeking a Lab & Mfg Systems Engineer for our client based in Sligo. The Lab & IT System Engineer primary duties will include but not be limited to providing hands on end user support, administration, installation, and issue resolution for GxP controlled laboratory and Business Technology Solution (BTS) systems, servers, desktops, and software packages.Why you should apply:
What you will be doing:
What you need to apply:
