Software Validation Consultant

Posted 7 March by Scimcon

Scimcon is recruiting talented individuals for immediate project work

Role- Computer Systems Validation Lead.

Project - Implementation of clinical trials electronic diaries.

Reporting To -eDiaries Programme Manager


* Ensuring the clients Quality Standards are represented within the project.

* Liaising with software vendor and the study delivery teams.

* Creating and maintaining project documentation sets.

* Creating and contributing to documentation deliverables according to the client’s project management methodology.

* Developing and implementing project Validation Models.

* Delivering validation services

- Create validation plan

- Document user requirements

- Map requirements to test script / steps

- Write OQ & PQ test scripts

- Execute OQ & PQ scripts

- Create validation report

* Identifying and contributing to Standards, SOP and Work Instruction updates to reflect system changes.


Great work creates good relationships, built on trust, breeding reliance.

And that means our clients always want more of us.

So more of us there must be.

We’re actively recruiting across all relevant areas of expertise, to make our little team a little larger.

If you like the idea of working in a niche consulting company with more responsibility, the opportunity to be hands-on in detailed projects and the chance to see your work make a real difference to clients read on

Be a big part of a small company

Scimcon is a niche company with very specific expertise. We’re not the largest consultancy, nor are we likely to be in the FastTrack100. But our size belies our impact.

In the first place we’re able to get close to our clients, unfettered by the process and procedures that obstruct larger consulting firms. We enjoy a degree of freedom in how we run projects, as a team, or as individuals.

We all know our area and the whole team is committed to solving clients’ problems, but not in a rigid way. We like to think differently, to be flexible in developing solutions, and to support one another throughout.

If empowerment sounds appealing, or having few constraints, and being able to make a difference to clients, you may like being part of Scimcon.

Of course, we need your expertise and experience…

We’re looking for the right people to expand our capacity in all areas of our business.

Whatever the role, we rely on everyone having clear understanding and experience of the full range of lab software systems, including:

  • Clinical trials management software
  • Electronic lab notebooks
  • LIMS
  • Chromatography data systems

Validation experience
The secret of successful and painless validation is in really knowing the software and the regulatory environment.

You should have experience of both. And instinctively know how to test the system performance.

Ideally, you’ll be inclined to writing test scripts that save time and effort for the client and validate systems as efficiently as possible.

QA experience
Ideally you will have experience in regulated pharmaceutical environments, understanding the rigours of that world.

You should understand and have experience of managing the whole process, implementing policies and procedures to meet regulatory demands, including remedial work and longer-term risk assessment.

…But what we’re really looking for is attitude and aspiration

Recruit attitude, teach process. That’s the number one rule we observe when adding new people to our team.

Of course we expect some experience and ideally a slab of lab history, but the key qualities are individual ability and commitment.

Our consultants make the job what they want it to be, they are individualists. It’s a distinct advantage of the smaller consultancy that the space exists to drive the job your own way, and we encourage it.

Our experts are also leaders. They grow in confidence and in ability to build support with their clients, to get people on-side - giving clients answers, recommendations rather than questions.

We have tried to create a supportive environment that aids encourages our people to challenge their approach and seek new ways to solve old problems. We’re looking for people who respond to that freedom finding in it more opportunity to grow.

Small, but with surprising opportunities

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Required skills

  • Clinical Trials
  • Pharmaceutical
  • Validation
  • Test Scripts

Reference: 34629435

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