As the Senior Computer Systems Validation Engineer you will be working to ensure conformance to quality systems, to liaise with various departments, and give guidance, review documentation and ensure the company validation policies & procedures are being adhered to.

An ambitious Intermediate level Equipment & Process Validation Engineer will also be considered for this role

Responsibilities

Managing and co-ordinating the preparation, review and approval of the Validation Master Plans

Managing and co-ordinating of all validation strategies and deliverables

Development and maintenance of internal validation policies and procedures based on best international standards and practices

Auditing of internal projects against internal validation policies and procedures

Managing and co-ordinating the preparation, review and issuing of validation protocols and reports

Managing and co-ordinating validation documentation including risk assessments, traceability matrices, and validation reports

Managing and co-ordinating the review and approval of specifications associated with Equipment, Processes, Products and Computerised Systems

Managing, co-ordinating and directing all validation and revalidation activities

Reviewing, managing and approving change control forms for Validation/Compliance implications

Managing and co-ordinating routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise

Updating existing quality documentation related to validation activities

Identifying training requirements for project team members in support of validation

Managing and co-ordinating risk assessments for customer projects

Developing and reviewing software validation plans, test protocols, test data and test reports for embedded medical device

Provide technical direction in the development and review of software requirements

Managing and co-ordinating the design and implementation of software validation processes on projects

Work closely with software engineering team to ensure implementation and application of software validation principles throughout the development process

Provide technical direction and hands-on assistance for testing projects

Reviewing vendor validation documentation

Managing and co-ordinating all project validation activities (including the vendors)

Motivates & coaches team to enhance performance

Work closely with the commercial department to assist in opening new client opportunities and generation of client proposals

Makes articulate and effective presentation to a variety of audiences, large or small, internal or external

Effectively communicates and constructively defends results of own work or teams’ work at technical presentations in-house, with clients, and at technical meetings

Liaising with customer departments

Addressing customer feedback and providing progress updates to customers

Requirements

Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline

Over 5 years’ experience as a Validation Engineer (mainly computer validation) in the Pharmaceutical or related Healthcare industry

Experience of GxP Computerised Systems

Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements

Familiar with the GAMP5 guidelines

Experience with serialization

Experience with Systech Technology

Excellent communication skills, including ability to advise and influence

Excellent attention to detail

Excellent understanding of validation concepts and documentation

Excellent communication skills, including ability to advise and influence

Should be based within a commutable range or else willing to re-locate for 1 year period

Expected to be on site during the project with the exception of attendance at any FA

Why Choose This Role & SL Controls

An excellent salary and benefits package including pension and health cover and other benefits such as:

Educational assistance

Income protection scheme

Wellness and health initiatives

The opportunity to work with clients who are global leaders in their field

A supportive environment committed to employee development and wellness

The opportunity to work with and help develop and improve upon industry leading technology solutions

A collaborative and open culture where you are valued and have the opportunity to contribute to company initiatives and growth

About SL Controls

SL Controls 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 16 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Dublin and Florida. We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.