+353-21-4834930 Specialists in Life Science Automation and IT Systems
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SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
Why SimoTech
What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.
Software Support Engineer 1585
SimoTech is currently seeking an experienced Software Support Engineer to join our team, working in a hybrid role with key client within the biopharmaceutical manufacturing sector in Cork. This role provides an opportunity to be a key contributor in the operation and optimisation of vital business systems within the highly regulated life sciences environment.
In this role, you will be responsible for the enhancement, continuous improvement, and support of essential software application and tools. This position is embedded within a well-established team and will partner with IT and Automation Engineers specialising in a variety of areas including MES, Data Analytics, Infrastructure, and Validation.
Key Responsibilities
* Maintain and optimise existing systems to improve performance and reliability, ensuring high availability and compliance with pharmaceutical regulations.
* Carry out technical troubleshooting and root cause analysis for software related issues in the manufacturing facility, working with Level 2 and 3 applications.
* Take the lead on specific daily work activities of the team including customer incidents and change requests, along with system and data issues.
* Collaborate with external vendors to carry out technical design specifications, troubleshooting, source code reviews, etc.
* Collaborate with cross-functional teams including scientists, engineers, and IT to understand requirements and implement system improvements.
* Translate business requirements into low level technical requirements.
* Document deviations and change controls in line with the site QMS system.
* Develop and maintain comprehensive documentation, including design, security protocols, testing procedures and change protocols, as well as system procedures.
* Develop, maintain, and carry out multi-level system testing.
* Ensure consistent adherence with company quality standards and practices, particularly in producing and maintaining all relevant system validation documentation.
* Monitor system performance and implement proactive measures to prevent downtime or data discrepancies.
* Deliver regular updates to key stakeholders on project or activity status and the escalation of critical issues to the appropriate business areas and management.
* Manage ongoing compliance activities and facilitate audits and inspections including periodic review, audit trail reviews, and access roster reviews by providing comprehensive technical documentation and system insights.
* Promote the use of system functionality and new technologies to improve work processes across the organisation.
Qualifications
* Degree or qualification in IT or related field, or equivalent practical experience.
* 7+ years’ experience delivering and supporting IT software solutions.
* Strong documentation skills with good knowledge of change controls process, GMP, and data integrity requirements within the pharmaceutical or life sciences industry is essential.
* Strong manual software testing experience.
* Strong analytical, troubleshooting, and problem-solving skills.
* Demonstrated willingness to learn both technically as well as business processes and applications.
* Excellent communication and interpersonal skills with the ability to work on your own initiative and collaborate effectively with business teams and third parties.
What SimoTech Can Offer
* Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
* Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
* Opportunity to work with large corporate clients on exciting capital projects.
By submitting my data (CV), I consent to SimoTech collecting and storing my personal data, as outlined in the SimoTech Privacy Statement which I have read.
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