Automation/IT

This full-time permanent role is Hybrid, working two days a week in our client’s Glasgow offices (Tuesdays and Thursdays) and three days a week from home (Mondays, Wednesdays, and Fridays).

Do you want to work for a founder managed, high growth & pioneering company who offer market leading purchasing and supply chain management services which ultimately allow Biotech, CRO & Academic organisations to focus on discovering life changing scientific innovations?

Are you already a CSV Specialist/Engineer with demonstrable experience of validating GxP software systems in the Life Science, Biotech or Pharmaceutical industry, including the generation and execution of all validation lifecycle documents?

If you have said yes to the above, then this new Computer System Validation Specialist role created due to our client’s growthcould be the perfect career move for you!

The responsibilities of the Computer System Validation Specialist – Life Sciences:

  • Software evaluation: Assess the software functionality, identifying areas requiring validation and conduct detailed risk assessments to identify potential areas of non-compliance in the software
  • Validation Lifecycle: Manage the full lifecycle of validation projects from initial assessment to post-validation summaries, ensuring quality and consistency at every stage
  • Validation Strategy: Design and develop comprehensive software validation strategies and plans to ensure our software meets required standards and regulatory compliance.
  • Validation Protocol Design: Create detailed validation protocols, in accordance with appropriate regulatory requirements, the companies Quality Management System and current industry practice
  • Testing: Execute or oversee the execution of validation test cases, ensuring they adhere to the set protocols
  • Documentation management: Generate, review, and maintain all necessary validation documentation
  • Collaboration: Work closely with customers, Inventory Onboarding, and other internal teams to ensure synchronisation of efforts
  • Regulatory Adherence: Stay updated on relevant industry regulations, standards, and guidelines to ensure that validation processes and documentation are compliant.
  • Process Improvement: Review and optimise validation processes and methodologies, keeping abreast of industry best practices
  • Incident Management: Report and address any Quality Management System noncompliance related to validation

The requirements of the Computer System Validation Specialist – Life Sciences:

  • Demonstrable experience of validating GxP software systems in the Life Science, Biotech or Pharmaceutical industry, including the generation and execution of all validation lifecycle documents
  • Proven ability to interpret, understand, and apply relevant guidelines, regulations, and standards to maintain validation compliance
  • Bachelor’s degree preferred, for example in a science or technology-based degree
  • Comprehensive knowledge and understanding of the regulatory requirements including FDA 21 CFR Part 11
  • Knowledge and understanding of Good Manufacturing Practice guidance
  • Excellent communication skills and enjoys building rapport and relationships with internal teams and customers.
  • Proven track record in managing and delivering projects with excellent organisational skills
  • Excellent Attention to detail
  • Strong willingness to champion validation processes and advocate for adherence to regulatory requirements throughout project lifecycles

Salary & Benefits:

  • Base Salary Circa £50,000 - £60,000
  • Annual profit-sharing scheme (between 9% - 19% of base salary)
  • Private Pension (5% matched and rising to 8% after 5 years)
  • Private Healthcare
  • 3x base salary in life insurance
  • Hybrid working and flexible hours
  • 22 days holiday + 9 bank holidays
  • Laptop & Phone

Apply right now by calling Oliver Gill – Global Recruitment Manager at Langton Howarth Ltd on + 44 (0) 113 243 3499 and email your up-to-date word CV to olivergill@langtonhowarth.com Langton Howarth is the market leading scientific supplies company placing people into dream jobs across the UK and Europe daily.

To be considered for this role you must have full right to work in the UK and a valid UK driver’s licence.

Langton Howarth also operates a recommend a friend referral scheme. So, if you know someone who could be good for this job, email your nominated candidate’s name and contact details in confidence via email too, and we will ensure you receive £100.00 of vouchers from a high street retailer of your choice!

Job Features

Job CategoryAutomation/IT

This full-time permanent role is Hybrid, working two days a week in our client’s Glasgow offices (Tuesdays and Thursdays) and three days a week from home (Mondays, Wednesdays, and Fridays). Do you w...

Remote home-based role with weekly field-based travel to customer sites across the UK & overnight stays as required each month

Do you want to work for a market leading global medical technology company whose cutting edge products, software & services are used to save and improve the quality of lives in areas such as Intensive Care, Cardiovascular Surgery, Sterile Reprocessing, Digital Health & Pharmaceutical Production?

Do you already have 2+ years experience in any manufacturing based industry or the healthcare/medical devices sector already in an IT/Software focused IT Engineer, IT Applications Support, IT Helpdesk or related IT support role that involves system administration, database management or applications support?

If you said yes to the above and have a valid driver's licence, then this brand-new role could be perfect for you!

In the role of Field IT Applications Support Specialist:

  • In this fast paced and exciting Field IT Applications Support Specialist role you will perform installation, configuration, and maintenance of my client’s specialist Surgical Instrument Management Software both in person at hospital sites and remotely
  • Offer support using Telephone, Email, Support ticketing System, remote SW tools and on-site customer visits
  • Ensure that high customer-focus and satisfaction is the basis of all activities
  • Take ownership for enquiries and escalated issues, to ensure they are efficiently prioritised and resolved in line with my client’s procedures, workflows, policies, and service level agreement (SLA’s)
  • Ensure that assigned cases are handled quickly, courteously, and efficiently in line with departmental standards, workflows, policies, and procedures
  • Trouble shoot and where possible reproduce issue to identify/propose solutions on software, hardware, and operational issues
  • Record and document carefully all activities in ticketing system
  • Highlight any common issues/recurring issues received and alert to line manager
  • Escalate as appropriate and in accordance with workflows
  • Register customer complaints according to workflow Participate in 24/7 duties outlined by the Applications Team Leader
  • Perform review / consultation / supervision / training / other tasks outlined by the Applications Team Leader

The requirements of the Field IT Applications Support Specialist:

  • 2+ years experience in any manufacturing based industry or the healthcare/medical devices sector already in an IT/Software focused IT Engineer, IT Applications Support, IT Helpdesk or related IT support role that involves system administration, database management or applications support
  • Basic knowledge of Microsoft Office Word, Excel, PowerPoint, Outlook, Visio, and CRM applications is required
  • Excellent attention to detail
  • Strong communication skills and ability to communicate and explain technical information at all levels
  • A high professional level of English, both written and spoken
  • Electrical skills are an advantage
  • Ability to create and maintain strong relationships with customers
  • Structured, analytical, and methodical in approach and attitude to maintain an overview of cases and carry through
  • Solid general IT and SW skills (Windows, Linux, SQL DB, Networks)
  • Pro-active in mind and action to deliver best in class support
  • Ability to keeping a good overview and to prioritise
  • A team player with a flexible approach
  • Full UK Driving Licence and right to work in the UK are both essential

Salary & Benefits:

  • Base Salary Circa £30,000 - £40,000
  • £200 per month on call supplement (£2,400 per year)
  • Tesla Model 3 Company Car (Fully Expensed)
  • Pension
  • Private Healthcare
  • Wellness & Training Programs
  • 25 days holiday + 8 bank holidays
  • Laptop & Phone

For more information about the role or to apply send your CV now to olivergill@langtonhowarth.com or call Oliver Gill today on +44 (0) 113 243 3499.

You must have the right to work in the UK and a full UK drivers licence to be considered.

Langton Howarth also operates a recommend a friend referral scheme. So, if you know someone would be good for the role, email your nominated candidate’s name and contact details in confidence via email too, and we’ll ensure you receive £100.00 (o/e) of vouchers from a high street retailer of your choice once we have successfully placed the person referred by you.

Job Features

Job CategoryAutomation/IT

Remote home-based role with weekly field-based travel to customer sites across the UK & overnight stays as required each month Do you want to work for a market leading global medical technology co...