Process Engineer in Pencoed

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world‑leading in‑vitro diagnostics company with award‑winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritises actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

As QuidelOrtho continues to grow, we are seeking to appoint a Process Engineer to join our Engineering department in Pencoed on a permanent basis. This role will work a standard work week.

About QuidelOrtho, Pencoed: QuidelOrtho has been manufacturing products in South Wales for over 40 years. Our state‑of‑the‑art manufacturing facility, based in Pencoed, employs over 600 people who are involved in the manufacture and supply of clinical laboratory and immunohematology products to sites across the globe. Our Pencoed team manufacture a large menu of immunohematology products used in transfusion medicine; in addition to a large menu of immunoassay products encompassing a range of disease categories. On site we have a range of functions operating globally & locally. All our employees are working towards one common goal, to help save and improve lives through diagnostics.

Your new role:

• Maximise process equipment performance by leading cross‑functional teams to identify and eliminate waste attributed to poor process equipment performance through incremental process improvement projects.
• Manage the engineering non‑conformance process through to corrective action via the site’s quality process.
• Lead cross‑functional project teams, defining roles and responsibilities.
• Champion continuous improvement initiatives such as quality circles, benchmarks and leverage opportunities.
• Demonstrate the skills needed to efficiently resolve both operational and process equipment issues.
• Lead continuous improvement of routine process procedures, including standard setup for critical equipment.
• Facilitate teams to conduct effective root cause analysis, Failure Modes and Effect Analysis, Reliability‑Centred Maintenance (RCM) and Total Productive Maintenance (TPM).
• Lead maintenance technicians in the development of machine performance metrics linked to the site goals.
• Analyse data and select appropriate tools to ensure equipment operates to sustain customer supply.
• Manage project risks and issues proactively and effectively to ensure the desired outcome is achieved.
• Plan and prepare for change using appropriate tools.

Quality and Compliance Related Responsibilities:

• Ensure all activities are carried out in compliance with all regulations and laws governing business and quality operations (QSR/GMP, ISO, etc.).
• Ensure all activities comply with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental (HSE) compliance.
• Provide effective and timely closure of assigned non‑conformance activities – e.g., CAPA’s.
• Conduct activities in accordance with the site safety policy documents (Engineering Request, Permit to work, Lock‑out procedure, etc.).

What You’ll Need to Succeed:

• HND (Minimum) / Degree in an engineering discipline.
• Professional qualification e.g., I.Eng, etc. (Mech./Elec./Control) would be desirable.
• Previous experience in a similar role ideally in a highly regulated manufacturing environment (Diagnostics, Medical Devices, Pharmaceuticals or Consumer).
• Problem‑solving skills for quick and effective implementation of process improvements and overcoming maintenance related issues.
• Ability to effectively lead cross‑functional disciplines within the Pharma or Diagnostic/Healthcare industry.
• Excellent organisational and time‑management skills.
• Appropriate knowledge of health, safety and environment system requirements.

What we offer:

• Competitive salary
• Yearly salary reviews
• Attractive pension scheme
• Bonus scheme
• Life assurance
• Private medical (If applicable)
• LinkedIn Learning
• Cycle to work scheme
• Free onsite gym
• Subsidised canteen
• 25 days holidays + 1 QuidelOrtho day + 8 bank holidays (milestone increases available)
• Employee assistance programme
• Reward & recognition programmes
• State‑of‑the‑art facilities
• Exceptional career developmental prospects
• Strong culture centred around collaboration & customer focus

QuidelOrtho believes in equal opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, colour, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job‑related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.