Validation Technical Leader (Computerised Systems Validation)

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Validation Technical Leader (Computerised Systems Validation), Craigavon

Client:

Almac Group

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

6335988c5168

Job Views:

2

Posted:

18.04.2025

Expiry Date:

02.06.2025

Job Description:

Validation Technical Leader (Computerised Systems Validation)

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

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.

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.

1. 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.
2. Significant Experience in a CSV role within the Pharmaceutical Industry.
3. Experience Reviewing and approving cGMP Validation Documentation.
4. Understanding of Pharmaceutical Industry Regulations and Guidance related to CSV/DI, including change management.

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.

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