Senior Commissioning and Qualification Engineer

The Role:

• Senior Commissioning and Qualification Engineer
• Sligo
• Onsite role no remote working so you must be living within a reasonable commute of the Sligo site
• Permanent or Contract

Role Brief:

The successful candidate will work within the Engineering department with a key SL Controls client. The role reports into the a Senior Process Engineer and will have responsibility for the generation and approval of a range of Qualification Life Cycle documents from SLIA through to PQ and Final Summary Reporting for Direct Impact Systems.

Core Responsibilities:

• Generation / Approval of Qualification Life Cycle documents from SLIA through to PQ and Final Summary Reporting for Direct Impact Systems.
• Generation of Commissioning Test documents for No Impact Systems.
• Implementation of Change Controls on the change management system to support project activities as applicable.
• Coordination and management of all elements of commissioning & qualification of large and small scale projects.
• Developing a project plan and qualification strategy in line with client requirements.
• Coordinate and supervise third party suppliers / vendors service providers and subcontractors as necessary.
• Monitor and report on project plan progress communicate any shortfalls in specific areas of the plan and identify solutions to address the shortfalls.
• Participate in decision forums to decide on priorities and ensure these are reflected in the plan schedule and communications.
• Evaluate allocation of resources needed to complete project tasks and provide recommendations to maintain required progress.
• Monitor budgets closely reporting on funding committed expenditure forecasting and progress.

Skills Brief:

• Able to demonstrate a knowledge of Systems and Equipment and engineering design.
• 5 years experience in projects in the Pharmaceutical or Biotech/Medical devices sectors in a majorproject environment.
• Clear understanding of a range of automation systems technologies regulations and standards.
• Proven track record in a project delivery focused role in the above industry sectors.
• Project engineering skills including budgeting vendor and the generation and approval of Qualification Life Cycle Documentation.
• Experience in commissioningandqualification of projects of low medium and major complexity.
  

Person Brief:

Candidates must have a B.Sc. degree in Engineering or equivalent electrical electronic or automation discipline with a minimum of 5 years experience in aGMP manufacturing environment such as pharmaceutical biotechnology or medical devices. The ideal candidate will have excellent communication skills and strong problem skills.

As this is an onsite role in Sligo you should be living within a reasonable commute and be able to attend the site daily or you will be able to relocate within 1 to 2 months maximum.

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.