Role Brief:
The successful candidate will provide technical support and project management to all manufacturing operations and NPI’s throughout the site. You will provide technical leadership of all control system activities in a medical device manufacturing facility for a key NNIT Ireland client.
Core responsibilities:
1. Take ownership of control system qualification activities during project start-up.
2. In conjunction with IT, lead the integration of new systems.
3. Manage control system elements of new and continuous improvement projects.
4. Work closely with process engineers and other departments to deliver these projects.
5. Manage and technically develop future integrations of control systems, including planned MES/ERP/Data Historian (OSI PI) systems.
6. Manage the lifecycle of on-site control systems in compliance with applicable regulatory requirements.
7. Provide technical support for control system issues, including troubleshooting, optimization, and documentation control.
8. Adhere to and support all EHS & E standards, procedures, and policies.
9. Identify opportunities and assist in leveraging vendor qualification efforts, develop relationships with vendors, and act as Engineering representative for pre-approval of vendor documentation.
Skills Brief:
1. Experience in a GMP regulated environment is essential; candidates with Pharma, Life Sciences, Biotech, or Medical Devices manufacturing experience will be considered.
2. At least 3 years of experience in an automation engineering role, with software development experience in PLC / HMI / SCADA platforms within a GMP pharmaceutical environment.
3. Strong knowledge of 21 CFR Part 11 requirements for automated systems in the pharmaceutical industry.
4. Proven experience in plant start-ups and/or new product introductions in medical device facilities, with leadership in start-up environments.
5. Experience in control system qualification is essential.
6. Experience in auditing and internal inspection is advantageous.
Person Brief:
Candidates must hold a B.Sc. degree in Mechatronics, Automation, or a related field, with a focus on software development, electrical, electronic, or automation disciplines. A minimum of 3 years’ experience in pharmaceutical, biotechnology, medical devices, or a relevant GMP manufacturing environment is required. The ideal candidate will have excellent communication and problem-solving skills.
Note: The role is onsite in Sligo. Only candidates within a reasonable commute or willing to relocate within a reasonable timeframe, and not requiring a work permit, will be considered.
Opportunity Brief:
This is an excellent opportunity to work with global industry leaders, contributing to the development and enhancement of industry-leading technology solutions. NNIT Ireland offers a supportive environment focused on employee development and wellness, along with a competitive compensation package.
Company Brief:
NNIT Ireland specializes in Equipment System Integration and System Support, assisting top multinational companies in the medical device and pharmaceutical sectors to achieve Six Sigma and OEE targets. Over 20 years, we have grown from a Sligo-based enterprise to an international business with offices in Galway, Limerick, Leinster, and Florida, USA. We pride ourselves on expertise in industrial IT integration and regulatory compliance.
About NNIT
NNIT is a publicly listed company providing IT solutions to life sciences globally and to the public and enterprise sectors in Denmark. We focus on high-complexity industries, supporting environments with high regulatory demands. We build sustainable digital solutions for patients, citizens, employees, and end users. NNIT comprises NNIT A/S and subsidiaries SCALES, Excellis Health Solutions, and SL Controls, employing over 1,800 people across Europe, Asia, and the USA.
We celebrate diversity and are committed to creating an inclusive environment. All candidates are encouraged to apply regardless of gender, age, religious beliefs, sexual orientation, origin, political views, disability, race, skin color, or ethnicity.
In the interest of a fair recruitment process, we kindly request candidates not to include pictures in their applications.
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