Validation specialist

2 weeks ago

Glasgow, United Kingdom Langton Howarth Full time

Computer System Validation Specialist – Life Sciences
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
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: Regulatory Adherence: Stay updated on relevant industry regulations, standards, and guidelines to ensure that validation processes and documentation are compliant.
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
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
Strong willingness to champion validation processes and advocate for adherence to regulatory requirements throughout project lifecycles
Annual profit-sharing scheme (between 9% – 19% of base salary)
~ Private Pension (5% matched and rising to 8% after 5 years)
~3x base salary in life insurance
~ Hybrid working and flexible hours
~22 days holiday + 9 bank holidays
~ Laptop & Phone

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. 00 of vouchers from a high street retailer of your choice
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