CSV Engineer Lead

The Role:

• CSV Engineer Lead
  
• Onsite Sligo
• Permanent/Contractor

Role Brief:

As our Lead CSV Engineer you will be working on generating validation docs collaborating with the global validation team and coordinating executions along with the automation team members.

Responsibilities:

• Managing and coordinating the preparation review and approval of the Validation Master Plans
• Managing and coordinating 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 coordinating the preparation review and issuing of validation protocols and reports
• Managing and coordinating validation documentation including risk assessments traceability matrices and validation reports.
• Managing and coordinating the review and approval of specifications associated with Equipment Processes Products and Computerised Systems.
• Managing coordinating and directing all validation and revalidation activities.
• Reviewing managing and approving change control forms for Validation/Compliance implications.
• Managing and coordinating 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 coordinating 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 coordinating 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 handson assistance for testing projects.
• Reviewing vendor validation documentation
• Managing and coordinating 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 inhouse with clients and at technical meetings
• Liaising with customer department
• Addressing customer feedback and providing progress updates to customers

Skills Brief:

• 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 &Systech Technology
• Excellent understanding of validation concepts and documentation.
• Expected to be on site during the project with the exception of attendance at any FAT

Person Brief:

Successful candidates should have aBachelors degree in Computer Science Electrical Engineering Systems Engineering Technology or a related discipline.

You should have at least5 years experience as a Validation Engineer (mainly computer validation) in the Pharmaceutical or related Healthcare industry with experience leading a successful team.

Candidates should also possess excellent communication skills including ability to advise and influence and strongattention to detail.

You must alsobe located within the RepublicIreland with commutable distance to Sligo as this will be fully onsite.

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. SL Controls offers a supportive environment committed to employee development and wellness along with a competitive and rounded compensation package which rewards high performers.

Company Brief:

SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers including many of the worlds 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 OEMs and Technology providers.

Find out more about working at SL Controls our Sustainable Development Goals and our Diversity Equity and Inclusion policy.