Computer System Validation (CSV) Lead – Lab Execution Systems (LES)

TN United Kingdom; Liverpool; On-site; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Computer System Validation Lead to oversee the CSV strategy for Lab Execution Systems. In this pivotal role, you will manage the validation program, ensuring compliance with industry standards and maintaining the validated state of systems. With a strong focus on quality, you will coordinate with global teams and utilize advanced validation lifecycle management applications to support CSV phases. This opportunity offers a chance to contribute to innovative solutions in a dynamic environment, making a significant impact on the pharmaceutical sector.

Qualifications

• 7+ years of experience with CSV methodologies in Lab Execution Systems.
• Experience writing, reviewing, and executing CSV documents in GAMP 5 framework.

Responsibilities

• Manage the CSV program for Lab Execution Systems and application interfaces.
• Oversee the preparation, delivery, and execution of CSV deliverables.

Skills

Computerized System Validation (CSV)

Lab Execution Systems (LES)

System Development Lifecycle (SDLC)

Data Integrity principles

GAMP 5 CSV framework

Laboratory Information Management Systems (LIMS)

Chromatography Data Acquisition System (CDAS)

ALM platforms (Kneat, Codebeamer)

Education

Bachelor's in Engineering

Bachelor's in Computer Sciences

Tools

Kneat

Codebeamer

Job description

Job Description

Your Role

The Computer System Validation Lead – Lab Execution Systems (LES), will be responsible for executing the Computerized System Validation (CSV) strategy and deliverables for global and Lab Execution Supporting Systems and related interfaces.

This role is part of a global function and can be based from our manufacturing sites in Melbourne, Australia or overseas.

Your Responsibilities

1. Manage the CSV program for Lab Execution Systems and application interfaces
2. Owner of the LES validation strategy in alignment with Quality
3. Oversee the preparation, delivery, and execution of CSV deliverables for Lab Execution Systems
4. Coordinate with Quality, Site and Global validation team to build alignment of LES validation expectations and maintain the validated state of LES platforms
5. Develop processes and maintain platforms
6. Manage System Development Lifecycle and validated state of LES platforms
7. Accountable for the Periodic Review process for documentation and systems
8. Use validation lifecycle management applications such as Kneat to support CSV phases

Your Experience

1. Bachelor's in Engineering, Computer Sciences, or similar field
2. 7+ years' experience with CSV methodologies in Lab Execution Systems, operation IT, OT, or Automation position with a good understanding of pharma, biologics and chemistry
3. Experience in writing, reviewing and executing CSV documents in a GAMP 5 CSV framework
4. Demonstrated knowledge and experience with CSV, SDLC, and Data Integrity principles
5. Experience with Lab Execution Systems technologies that may include Laboratory Information Management Systems (LIMS), Chromatography Data Acquisition System (CDAS) and Laboratory Data Management systems
6. Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5
7. Experience using ALM platforms such as Kneat and Codebeamer to support CSV

To apply submit your CV no later than Monday 15th July 2024.

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