Computer Systems Validation Engineer

The Role:

• Computer Systems Validation Engineer
• Kilkenny
• Onsite role – some remote work may be possible at times but the role is designated onsite
• Permanent or Contractor opportunity

Role Brief:

Working with a major NNIT Ireland client in the Pharma sector you will be responsible for the validation and management of a range of computerized systems within a high tech regulated manufacturing environment. The role will focus on the configuration and validation of manufacturing systems software with a focus on MES (Manufacturing Execution System). The role will, amongst other responsibilities support the MES implementation process.

Core Responsibilities:

• The validation and operational management of computerized systems.
• The configuration and validation of manufacturing systems software.
• Support of the configuration and validation of MES.
• The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
• Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
• Maintaining the quality and compliance status of associated Procedures, work instructions.
• Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.

Skills Brief:

• Strong experience in CSV for manufacturing systems and large-scale applications.
• A clear understanding and demonstrable experience in the configuration and validation of manufacturing systems software including MES is essential.
• Experience working with the implementation of an MES system is a definite requirement for this role.
• Full understanding of cGMP requirements including 21 CFR 11 and Annex 11.
• Excellent understanding of GAMP principles and validation concepts
• Demonstrated analytical and problem-solving capabilities.
• Strong technical writing skills.

Person Brief:

• Candidates must have a level 8 degree in Computer Science / IT/ Pharmaceutical Manufacturing or a highly related discipline
• 2+ years’ experience in a computer systems validation role in Pharma, Life Sciences or Medical Devices is essential – only candidates with this experience can be considered at this time
• The ideal candidate will have excellent collaboration and communication skills, strong attention to detail and able to communicate and present effectively to various levels of leadership
• Ability to think logically and be proactive.
• Must be flexibly and able to manage multiple priorities simultaneously.
• Must have excellent organizational skills
• The ability to be onsite daily is essential. Some remote working may be available but the role is designated onsite and may require a full time onsite presence. Therefore you must be able to commute daily to the site.

Opportunity Brief: 

This is an excellent opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry leading technology solutions. NNIT Ireland offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.

Company Brief:

NNIT Ireland are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets.

Over the past 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA.

We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.