Ortho Clinical Diagnostics

Senior Process Engineer

2 months ago(2/10/2017 11:22 AM)
United Kingdom

The Company

Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.  Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.


With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.


Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.


Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.


Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.

The Opportunity


As the company continues to grow, we are seeking an experienced Process Engineer.

Accountable to the Process Engineering Manager for the leadership and execution of improvement projects to support the Ortho UK Pencoed Operations business plan.

The Responsibilities


Continuous improvement

• Champion continuous improvement initiatives, benchmarks and leverage opportunities.
• Improve equipment and Instrument performance in terms of availability and yield. Knowledge of improvement techniques PDCA, SPC, IS / IS NOT / Ishikawa / along with timely delivery of commitments.
• Review, evaluate, leverage and adapt new technologies for the benefit of the business.

Equipment / Process support

• Experience with Rockwell / Siemens PLC’s FTTM, SCADA, Wonderware, MSSQL preferred
• Knowledge of vision systems (Cognex preferred)
• Robotics – ability to navigate / fault find to component level


Equipment Introduction

• Project Management – Execution of projects selected by the Pencoed site portfolio management team which may include :
• Management of customer and stakeholder expectations.
• Develop and implement appropriate project communication and support plans.
• Generating project business case - Project finance and budgetary control.
• Assignment and management of cross-functional resources.
• Management of project risks and issues proactively and effectively to ensure the desired outcome is achieved.


Standards or guidelines (GAMP) associated with Equipment Introduction. Which may include:

• Generating and approving User Requirement Specification (URS).
• Conducting Design and Construction Reviews.
• Managing equipment Installation, commissioning and Testing (FAT/SAT).
• Managing validation planning and execution activities (DQ,IQ,OQ,PQ).
• Generation of documentation to maintain the validated state (Training, SOP’s).


Quality and Compliance Related Responsibilities

• Effective and timely closure of assigned non-conformance activities – e.g CAPA’s
• Closure of project related CHIIP/CCR actions within the agreed timescales
• Ensuring all activities are carried out in compliance with all regulations and laws governing business and quality operations (QSR/GMP, ISO, etc.).
• Ensuring all activities comply with all local, national, international and company regulations, policies and procedures for Health, Safety and • Environmental (HSE) compliance

The Individual



• Minimum of a Degree in an Engineering discipline (Chem. / Mech. / Elec. / Control).



• Technical Capability – Intellectual capacity, experience and training to function across engineering discipline boundaries to lead equipment. specification, design, build and qualification and improvement.
• Ability and proven track record of leadership (small cross functional teams) in the process improvement arena.
• Problem Solving – Ability to lead structured problem solving and RCI. Data based decision making skills.
• Appropriate Knowledge of Quality Management System and GxP requirements.
• Appropriate Knowledge of Health, Safety and Environment system requirements.
• Delivering change - Initiating and leading activities that have business or cost impact.
• Functional Business Acumen – appreciates the business environment and impact on own priorities and deliverables. 
• Knowledge of PEx and Lean principles.



• Good working knowledge of Microsoft office tools for communication and reporting.
• Proven track record of process improvement and equipment implementation within a regulated environment.
• Structured problem solving methodologies.
• Documentation / Technical report writing skills.



• Six Sigma Green or Black belt
• Lean Methodologies knowledge
• GAMP Knowledge
• Experience with Rockwell / Siemens PLC’s FTTM, SCADA, Wonderware, MSSQL preferred
• Knowledge of vision systems (Cognex preferred)
• Robotics – ability to navigate / fault find to component level 




Equal Opportunity

At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career. 


Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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