Automation IT Technical Lead 1592

SimoTech; Cork; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

High degree of autonomy

Opportunity to work with innovative technologies

Career progression opportunities

Job summary

A leading technology company in Cork is seeking an experienced Automation IT Technical Lead. In this role, you will provide technical leadership and ensure compliance with regulatory standards in a life sciences manufacturing environment. The ideal candidate has over 7 years of experience in automation design and strong communication skills. Excellent opportunities for career progression and skill development are included in this role.

Qualifications

• Minimum of 7 years’ experience in automation design and interfacing to OSI PI.
• Experience in life science manufacturing environments is essential.
• Knowledge of GAMP and 21 CFR Part 11 standards.
• Experience in design, configuration and installation of Automation and IT systems.
• Experience in highly regulated GxP environments with understanding of GAMP and 21 CFR Part 11.
• Technical leadership and strong communication skills.
• Ability to work in a diverse, multi-disciplinary team and independently.
• Willingness to travel to mainland Europe on short notice.

Responsibilities

• Ensure compliance with industry standards including GAMP and 21 CFR Part 11.
• Guide facility and systems design as an SME.
• Communicate project updates to the Project Manager.
• Provide project updates to the Project Manager.
• Collaborate with IT and OT teams to maintain cybersecurity and compliance.
• Advocate for using system functionality and new technologies to improve work processes.

Skills

Automation design

Technical leadership

Communication skills

Problem-solving

Education

Bachelor’s Degree in Engineering, Computer Science, or similar

Tools

LIMS

MES

ERP

OSI PI

Job description

[phone] 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.

Automation IT Technical Lead 1592

We have a new opportunity for an Automation IT Technical Lead to join the SimoTech team, supporting one of our clients, a global leader in the medical technology field.

In this role, you will act as an Automation and IT subject matter expert (SME), providing technical leadership and ensuring technical design requirements are met & are in adherence with both internal and regulatory standards on data integrity, cybersecurity, and business continuity.

The ideal candidate will have previous experience working within a Life Sciences manufacturing environment, excellent communication & interpersonal skills, and solid experience implementing automation design, interfacing to OSI PI and cybersecurity layers.

Key Responsibilities

• Ensure Automation and IT design is performed in compliance with industry standards including GAMP and 21 CFR Part 11.
• Act as an SME to guide and ensure facility and systems design meet company expectations.
• Exhibit up to date technical knowledge, ensuring strategy alignment and focus.
• Communicate regularly with and provide formal and informal project updates to the Project Manager.
• Collaborate with IT and OT teams to maintain cybersecurity and compliance standards.
• Advocate for the use of system functionality and new technologies to improve work processes.

Qualifications

• Bachelor’s Degree in Engineering, Computer Science, or similar.
• Minimum of 7 years’ experience implementing automation design and interfacing to OSI PI for cybersecurity projects, in a life science manufacturing environment, is essential.
• Must have a demonstrated knowledge of digital systems including LIMS, MES, and ERP and how they interact with the OT layer.
• Experienced in the design, configuration and installation of Automation and IT systems.
• Prior experience working within highly regulated GxP environments in the life sciences industry, with a good understanding of GAMP and 21 CFR Part 11 industry standards.
• Technical leadership skills.
• Ability to interact and communicate, both verbally and in writing, with other engineering and business disciplines.
• Ability to work well as part of a diverse, multi-disciplined team, as well as on own initiative.
• Excellent problem-solving skills.
• Please note: Travel to mainland Europe may be expected at short notice.

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.

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