Job Description

Job Requisition ID:

32568

Department:

Eng. - Validation (402)

Category:

Production

Location:

Wales

Date:

4 Jul 2025

Come and Save Lives with Us!

SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies.
For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world's leading portfolio of antidotes.
Today SERB has over 500 employees in 18 countries and group revenue in excess of EUR400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries.
Having the right culture is as important to us as having the right portfolio. We are guided by our four values:
We make patients our priority We act with accountability and integrity We work together as one team We look for better ways forward

By expanding our reach through selective acquisitions and entering new markets, we're not just supplying medicine; we're improving the standard of care for more patients around the world.

Broad Function

To deliver validation activities to support manufacturing at the Wales site, ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities. A member of the validation team who provides direct support to the efficient delivery of the Site Validation Master Plan (SVMP) Schedule.

Principle Responsibilities

1. Responsible for the completion of assigned validation activities on time in accordance with the SVMP schedule.

2. Generation of related project documentation and protocols for installation, operation and performance qualifications, Validation plans and reports

3. Execution of validation testing for manufacturing equipment, utility systems equipment, processes, cleaning validation, product hold times, and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.

4. To follow all Standard Operating Procedures (SOP's), Quality Records (QRs) and Batch Manufacturing Records (BMRs) and to participate in the generation, completion and review of such documentation when required, to agreed timelines.

5. To document all EHS incidents and cGMP events to agreed timelines using the required business systems.

6. To participate in subsequent root cause investigations and perform corrective and preventative activities that may be assigned, on time.

7. Liase with external contractors to arrange the completion of PPM activities, and the subsequent administration of PPM to closure
The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Education and Experience

? Educated to GCSE - HND/C standard in a relevant Science subject and / or experience of working in a manufacturing environment that employs a quality system (cGMP, ISO9001).

? Understanding or can show awareness of cGMP and EHS practices.

? An understanding of Lean Manufacturing principles and the application of 5S desirable.

? Computer literate.

Skills and Attributes

? High standards of attention to detail and the desire to see tasks through to completion.

? Must have good listening skills and be able to follow instructions and guidance.

? Must be able to work as part of a team and demonstrate initiative, when required.

? Must be able to train others and deliver clear instruction, when required.

? Must have a flexible, positive and willing attitude at all times.


Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.