Job Description

Validation Technical Leader (Computerised Systems Validation)

Location: Craigavon

Hours:

37.5 Monday-Friday with core hours 10:00-16:00.

Salary:

Competitive

Business Unit: Sciences

Open To

: Internal & External Applicants

Ref No.:

HRJOB10245/2

Please note this is a re-advertisement, if you have applied for this position recently there is no need to re-apply

The Role

The primary purpose of this role is to perform activities within the validation lifecycle of all GMP systems requiring computerised systems validation. This role is specifically in relation to Computerised Systems Validation (CSV) in accordance with pharmaceutical industry regulations and guidance. Systems will range from standalone equipment to complex multi-site enterprise level systems e.g. Delta-V Distributed Control Systems, Chromatography Data Systems, ERP, LIMS etc.



The post holder will be a positive role model, demonstrating excellence in technical and practical knowledge, customer care, planning, QA and results delivery. The role may require staff supervision.



This role assumes an excellent understanding and demonstrated knowledge of CSV, including Data Integrity, within the validation lifecycle. This allows the Technical Leader to not only perform their own activities but also provide advice to others from system selection through to delivery and ongoing compliance, including change management. The post-holder will be considered the CSV SME and will be required to attend and present at technical meetings and audits/inspections.


Please see attached job description for further details

Key Requirements

Applicants must have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full time, permanent employment in the UK


Essential Criteria


Degree (or equivalent) in Analytical Chemistry, Chemistry, Biochemistry, Engineering, IT or a related field

OR

significant relevant experience may be considered in lieu of Degree Level Qualification

Significant Experience in a CSV role within the Pharmaceutical Industry

Experience Reviewing and approving cGMP Validation Documentation

Understanding of Pharmaceutical Industry Regulations and Guidance related to CSV/DI, including change management


Please see attached job description for further details of essential and desirable criteria.

Apply Now

Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.

Closing Date

We will no longer be accepting applications after

8PM

on

Wednesday 30 April 2025

RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CV's received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.