Laboratory CSV Engineer

Posted 16 Jan 2019

Glasgow, Scotland - United Kingdom

Req Id 186700

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. 
 


We’ve identified a fascinating opportunity for a Computerised Systems Validation (CSV) Engineer to join our team in Glasgow. Joining a small team, you’ll be able to make a real difference to the business, working in an environment where you’re able to deliver key projects and improvements.

This is an incredible opportunity for someone to join our business at a time of rapid growth, to find a role where they can contribute to the business and make their mark really quickly. Working on some key projects you’ll also add to your professional experience and develop both as a Technical Specialist and as an individual.

Working with the Validation Manager and a team of other Validation Engineers, you will:

  • Support validation activities across all UK Sites (Glasgow, Stirling and Edinburgh)
  • Support training and development of all positions
  • Implement new systems and maintain validated status of all relevant equipment

This position is responsible for developing, reviewing, and managing the execution of CSV activities. In addition, ensuring that the qualifications are consistent with system/process owners requirements and applicable regulatory standards, verifying systems are fit for use and that data integrity is maintained at all times. The role will test your ability to work in a complex organisation, as on a daily basis you will also be interacting cross-functionally with Manufacturing, Process & Analytical Development, Quality Control, Quality Assurance, Engineering, and Maintenance.

What will I be doing?

To perform this role successfully we’re looking for someone who can:

  • Review and generate validation summary reports for executed qualifications and validations
  • Create validation schedules, coordinate execution efforts with contractors, laboratory staff, equipment support, and quality assurance staff members
  • Manage/Create and execute protocols for computerised systems, equipment, process controls, and facilities
  • Utilise Good Documentation Practice in a GMP atmosphere while generating protocols and reviewing documents
  • Review and generate summary reports for executed protocols
  • Ability to work through a Management of Change system to determine the impact of proposed changes to the qualification status of equipment, software, or facilities
  • Sound understanding of Quality Risk Management concepts

    In an ideal world we’re looking for a Technical Expert who can provide expertise in the following:

    • Computer Validation:
      • Develop Validation strategy for laboratory software systems such as;
        • Agilent OpenLab
        • GE Unicorn
        • MD Softmax
        • Waters Empower
      • Generation of software qualification protocols
      • Ability to review Functional and Design Specification documents for computerised systems
      • Solid understanding of 21 CFR Part 11, EU GMP Annex 11 and MHRA guidance on Data Integrity
      • Ability to implement appropriate methodology during the qualification of systems/infrastructure (e.g. GAMP5)
    • Equipment and Facility Validation:
      • Develop/Establish an overall plan for qualifying new equipment or new/upgraded facility and establishing the proper controls for the introduction of equipment/facility and/or changes under proper quality standards (e.g. FDA, EU GMP, ISO, ISPE, etc.)

Identify and establish revalidation requirements/periodic reviews

About you: 

Education and Training

  • Graduate level (or equivalent) with qualifications in engineering, computer science, quality assurance, or life sciences
  • Formal training in Validation ISPE GAMP 5 and Data Integrity training highly preferential

Specific Work Experience:

It’s essential that the successful candidate will be able to demonstrate the following professional experience.

  • A good level of direct experience with computerised system validation in a GMP environment and working knowledge of current regulatory and industry guidelines ie:
    • EU GMP Annex 11
    • FDA CFR Part 11
    • GAMP5 Methodology
    • Data Integrity (ALCOA+)
  • Comfortable in a fast-paced environment with the ability to adjust to changing priorities
  • Ability to articulate responses during Audits from Clients and Regulators
  • Flexible and accountable
  • Quality oriented work standards

 

And ideally, we’d like to find someone who also has the following experience and background:

  • Demonstrable computer validation experience in a cGMP manufacturing setting
  • Experience of HPLC systems with associated IT infrastructure.
  • Qualification of cloud based GMP applications
  • Knowledge of process control software.

Additional Requirements 

  • The post holder will be required to support all validation activities across all sites and therefore travel will be required across Central Scotland
  • Travel may be required for the execution of FAT’s/UAT (Up to 2 weeks per year)


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

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