Senior Validation Engineer
We are an Irish company that have devoted the past 30 years to delivering innovative custom automation, build to print and tooling solutions for the world’s most advanced manufacturers. Consecutively chosen as a Best Managed Company in Ireland by Deloitte for the past seven years, we are committed to always, always delivering the right solution. We specialise in designing and building bespoke, reliable, complete solutions which automate highly complex production processes. Through deep client collaboration we support our customers on the automation journey as they transition to smart methods of manufacturing that ultimately drive productivity and business efficiencies.
The role of the Senior Validation Engineer is to lead and deliver the required Validation package for bespoke automated equipment for a fast-paced, dynamic, and high technology Automation company working with customers in FDA regulated manufacturing sector.
This is a senior position operating in the Validation Department and reporting to the Department Manager.
The role of the Senior Validation Engineer is to own and deliver the Validation strategy and final Validation package throughout all stages of projects from proposal to delivery. This will encompass planning project validation documentation deliverables and testing and commissioning activity strategies aligned with project goals in a cost-efficient manner.
Proposal and project development will include working closely with the Commercial and Engineering Departments and the Customer to ensure the Validation package meets customer expectations and both internal and external commercial considerations.
This role requires advanced knowledge of GAMP requirements and as well as working knowledge of the disciplines involved in the software system development lifecycle of such bespoke automated equipment. This role will encompass planning project deliverables and validation strategies aligned with project goals.
This is a customer facing role with responsibility for meeting customer needs and nurturing partnerships with key customers.
- Third level degree in science or engineering discipline.
- A minimum of 5 years’ experience in a validation role within a Regulated environment.
- Previous involvement devising & deploying validation strategies, validation master planning, specific application validation strategies and managing execution & close-out activities.
- Knowledgeable of the Life Science regulatory landscape and industry trends in validation & compliance.
- Proven troubleshooting and problem-solving skills through technical proficiency and engineering creativity
- Extensive experience with generation of validation documentation (URS, PQMP-Project Qualification Management Plan, FMEA, VPP, Design Specifications, FAT, SAT, RTM, User manuals, & validation reports) and assist in the execution of FAT & SAT protocols for bespoke automated equipment and computerised systems.
Key Skills & Attributes:
- Strong documentation bias
- Attention to detail
- Analytical thinking
- Enthusiasm for working in a team across Departments
- Good written communication skills
- Preference for a structured approach to working
- Time management
- Customer focused
- Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines would be an advantage.
- Own the development, communication, and execution of the Validation Strategy for projects in accordance with GAMP, GMP/GEP and Customer requirements. This will require supporting the Project Engineering Leads and Project Manager to ensure the completion of key milestones and the management of documented evidence which verifies that such milestones have been met.
- Work to the Departmental project plan and schedule as determined by your Team Lead and/ or Department Manager.
- Act as the Validation Project Lead contact person and coordinator of machine validation/test activities.
- Monitor project variables (Time, Cost, Scope, Risk, Changes) and communicate the status of these to the Team Leader and Project Manager (as appropriate).
- Ensure best validation and test practices are employed across the company to maximize effectiveness and minimize non-value-adding work.
- Generate validation documentation (URS, PQMP-Project Qualification Management Plan, FMEA, VPP, Design Specifications, FAT, SAT, RTM, User manuals, & validation reports) and assist in the peer review and execution of protocols for machine validation activities.
- Contribute to the development of FAT/SAT protocols and executions.
- Leads in the planning of commissioning, qualification, and testing activities and in interfacing with Software Engineers, Production type Operators, and Engineering.
- Ability to handle multiple commissioning, qualification, validation priorities based on the needs of customers with guidance from management.
- Mentoring and delegating to junior engineers and co-ops including reviewing their work where necessary for accuracy, suitability and compliance with requirements and standards.
- Contribute to Lessons Learned reviews on projects
- Liaise with the customer to receive on time all the information needed for the project.
- Travel might be required.
Quality and Innovation
- Lead the project team, sharing “Modular Know-How” and support the project team on problem-solving
- Provide timely feedback on project team members to the Department Manager
- Contribute to the development of training plans for the team and support their implementation.
- Mentor junior team members
- Contributes to team effort by accomplishing related results as needed.
- Drive assigned continuous improvement tasks within the department
- Drive assigned department goals and objectives
- Present Validation Strategies with clear and effective communication
- Maintain clear structure & regular communications within the project team, department team and Team Lead
- Ensure communication takes place in a clear, timely, professional manner and records are maintained.
- Lead and feed into Project meetings from a Validation perspective
- Lead and feed meetings both internally and with Customers
- Communicate schedule risks, issues, and solutions with Team Lead and/ or Project Manager
- Collaborate across departments generating shared ownership of projects
- Attend project meeting -bringing up to date information on agreed templates and scope
To apply, please send your CV and Cover Letter to firstname.lastname@example.org