Validation Engineer

 

Kelso, United Kingdom

Full time

R026857

Be You – Our people create our best Plexus.  

Ingrained in our culture of inclusion is the philosophy that each individual offers diverse perspectives, backgrounds and experiences that create great outcomes when we are united as a team.

We embrace the differences of all our colleagues, celebrate diversity and welcome applications from underrepresented groups and candidates, regardless of their background. We are proud to be registered as the Disability Confident committed employer, and we recruit purely on the basis of skills and experience. 

Who we are and what we do? 

We help our customers deliver products to the world which have a profound impact on people’s lives. 
From ultrasound units and 3D printing to network security applications and in-flight Wi-Fi, we help create products that build a better world.
We’re a global team of experts who partner with our customers to bring their products to life through inspired innovation and world-class customer service.

Whether you’re looking to start, change, or advance your career find your path at Plexus and leave your mark on the world with us.

Purpose Statement:  The Validation Engineer is responsible for assisting the Senior Validation Engineer in leading the site in planning and executing equipment, process and product validations in accordance with all applicable regulations, standards and customer requirements.

 

Key Job Accountabilities:

 

Maintain the site Validation Master List (VML)

Assist in determining the validation strategy for product Validation Master Plans (VMP) in accordance with sector specific and customer requirements

Assist in the maintenance and update of product VMPs

Support identified users in the validation process

Coach trained users in best practices cGMP, GDP, etc

The use of appropriate statistical analysis tools to support site validations

Provide practical expertise and cGMP, GDP guidance in creation and execution of validation protocols, validation reports and other documentation.

Assist in determining and coordinating validation activities required as a result of site changes and new product introduction.

Provide timely review and approval of validation documentation

Maintain a working knowledge of all validation requirements, practices, procedures and industry trends for validation process and development.

Escalate issues and roadblocks that are preventing progress and success

Maintain and report validation metrics

Provide data and SME input in to the site Quality System Management Review, Metric Dashboard and Operations reviews as appropriate

Additional Accountabilities:

Assist in site internal audits

Assist in customer visits and audits

Assist in external registration or agency audits and Regulatory Inspections.

Actively Participate in the Global Validation user Group.

Additional duties as assigned.

Education/Experience Qualifications:

Industry experience preferred but persons with good aptitude and a keen attention to detail considered.

Good documentation skills and good organisation.

Some knowledge of Regulatory and Standards would be advantageous.

Some experience with direct customer interaction would be advantageous.

An equivalent combination of education and experience, sufficient to successfully perform the key job accountabilities may be considered.

Other Qualifications: 

Employee must be self-motivated with the ability to work independently and in a team environment.

Some training experience would be beneficial.

Good oral and written communication skills are necessary.

Attention to detail, and computer literacy are essential.

Project Management knowledge is advantageous.

General office equipment and materials.

 

Work Environment:

 

The work setting should consist of an office environment with suitable lighting, comfortable temperatures, and a low noise level.

This document does not represent a contract of employment and is not intended to capture every possible assignment the incumbent could be asked to perform.

Plexus is a global organization, whose headquarters are located in the United States and whose services are offered through its international affiliates. In order to meet the needs of its Customers, many of which are also international organizations, Plexus operates under a matrix organizational structure whereby employees are expected to interact with colleagues, managers and senior leadership in any of our international locations.  Therefore, although the position described herein is offered by Plexus Corp (UK) Limited, the services of the employee are rendered in a global or group-wide context.

For additional information on Plexus’ international locations, please visit https://www.plexus.com/en-us/about/locations.

 

Why you will love it? 

 

At Plexus, we’re at our best when opportunities are met with passion, open communication, and teamwork. Our employees work alongside a global team of experts who engage in projects that span a variety of industries – helping our customers in creating the products that build a better world. 

 

At Plexus, you will find:

• A workplace centered on collaboration and integrity
• Supportive leadership teams that value work-life balance through a flexible work environment
• An inclusive environment that values diverse backgrounds, experiences, and expertise
• Flexible career paths across a variety of disciplines
• Innovative design solutions and state-of-the-art technology that improves lives
• Through our commitment to local community involvement we encourage our employees to participate in outreach activities with charities, local Schools, Universities, and Colleges and to promote careers in the STEM fields

 

Additionally, when you join, we want you to enjoy what you do and be rewarded for your contribution, so we have a range of attractive benefits on offer:

 

• Bespoke development plan
• Online learning and formal development programs
• Full-time, permanent employment contract
• Enhanced pension contributions
• 33 days of annual leave (inclusive of public holidays) 
• Paid family leave
• Private medical insurance
• Group income protection insurance
• Employee Assistance Program (EAP)
• Electric Vehicle Salary Sacrifice Scheme 
• Cycle to work scheme
• Volunteer time off
• Flexible Hybrid Working Available (role dependent)
• Life assurance
• Occupational health
• Vision care discounts
• Discount schemes 
• Company sick pay scheme 
• Onsite gym/ discounted gym 

 

Application Process

We don’t look for culture fit, but culture add. We value all the perspectives our team brings to the table, and we want to hear from YOU. We encourage people from all backgrounds to apply to our positions, and will look at candidates holistically, balancing work, education and additional experiences.