Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 32 days ago

Computerised Systems Validation Specialist

Sharp Services115 open roles

Where
Rhymney
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowComputerised Systems Validation SpecialistSharp Services · Rhymney

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Sharp Services's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

13.1% of postings close within 7 days. Measured by our own scanner across the market. Sharp Services postings stay open a median of 16 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 13.1%7 days
  4. 21.1%14 days
  5. 35.7%30 days
  6. 58.7%60 days
This job: posted 32 days ago

Sharp Services median: 16 days open

The posting

Job Title: Computerised Systems Validation Specialist

Department: Quality

Location: Onsite/Hybrid – Rhymney, Wales

Summary:

Sharp is a global leader in clinical supply chain services and pharmaceutical packaging. For more than 65 years, we have supported pharmaceutical and biotechnology clients from phase I clinical trials through to commercial launch and lifecycle management. Our network includes facilities in the United States, the United Kingdom, Belgium and the Netherlands, together with more than 30 clinical depots providing global coverage.

We are pleased to be recruiting a Computerised Systems Validation (CSV) Specialist based at our UK site in Rhymney, Wales. This role offers onsite or hybrid working, with regular travel required between the UK and our European sites in Belgium and the Netherlands.

The Computerised Systems Validation Specialist will ensure that all IT systems affecting Good Manufacturing Practice (GMP) are appropriately validated and remain in a validated state throughout their lifecycle. The postholder will report to the CSV Quality Manager.

Duties and Responsibilities:

  • Maintain oversight of all IT systems and their CSV status. Manage and monitor the validated state of each system, ensuring that software and hardware modifications, changes and updates are assessed through the appropriate CSV process.
  • Maintain the Computerised System Validation Master Plan and all associated validation procedures, ensuring that they remain accurate, current and aligned with applicable requirements.
  • Maintain an up-to-date inventory of GMP-critical computerised systems, including each system’s owner, intended use and current validation status.
  • Prepare validation documentation for GMP computerised systems, including risk assessments, regulatory assessments, test protocols and validation reports.
  • Plan, coordinate and deliver validation activities in consultation with colleagues in IT, Operations, Supply Chain, Technical Services, Quality Assurance and Engineering, as appropriate.
  • Document validation activities and results accurately and completely, with responsibility for records relating to computerised systems validation.
  • Contribute to the continuous improvement and optimisation of people, processes, systems and procedures.
  • Assess validation requirements arising from proposed changes to systems, processes, installations or equipment, with responsibility for computerised systems and artwork management and control systems.
  • Support and, where appropriate, conduct internal audits across the relevant sites to identify opportunities to strengthen quality standards.
  • Act as the subject matter expert for CSV during external audits and regulatory inspections.

Competencies:

  • Demonstrates initiative and a proactive approach to delivering results.
  • Takes ownership of responsibilities and follows actions through to completion.
  • Able to organise and prioritise work independently while collaborating effectively as part of a team.
  • Uses sound judgement and takes a considered approach to decision-making.
  • Applies analytical thinking, considers different perspectives and remains open to alternative solutions.

Requirements (essential unless otherwise stated):

  • A bachelor’s or master’s degree in information technology or a related discipline is preferred.
  • Demonstrable experience in a pharmaceutical manufacturing or production environment.
  • Experience of planning, delivering and overseeing computerised systems validation or other validation studies.
  • Working knowledge of GMP requirements and relevant pharmaceutical regulations and guidance.
  • Experience of working with quality management systems, controlled procedures and regulated training processes.
  • Proficient in Microsoft Office applications and able to produce clear, accurate documentation.
  • Dutch language skills, both written and spoken, would be advantageous but are not essential.
  • Experience of preparing clear, accurate validation reports and technical documentation.
  • Able to travel regularly to Sharp sites in Belgium and the Netherlands, as required.

General:

  • This job specification is not exhaustive and may be amended to reflect changing organisational requirements following discussion with the postholder.
  • All employees are expected to understand and fulfil their responsibilities for health and safety, and to treat colleagues with dignity and respect in the workplace.

Sharp is committed to being an equal opportunities employer and to building a diverse and inclusive workforce. We welcome applications from all suitably qualified candidates, regardless of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex, or sexual orientation.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Sharp Services's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Sharp Services's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Sharp Services's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.