Validation Officer in Hitchin

Ransom Naturals Ltd (RNL), with over 175 years of expertise, is a leader in developing and manufacturing botanical extracts for the Pharmaceutical, Healthcare, Personal Care, and Food & Beverage industries. Based north of London, RNL operates a GMP-compliant facility approved by the UK Medicines and Health Products Regulatory Authority and specializes in producing Active Pharmaceutical Ingredients (APIs), excipients, and botanical extracts. The company combines traditional methods with innovative scientific techniques to meet the dynamic needs of global markets while providing extensive regulatory support. Its product range includes liquid, semi-solid, and powdered formats tailored to customer and market requirements.

The Validation Officer is responsible for planning, executing, and documenting validation and qualification activities across the site in accordance with current Good Manufacturing Practice (cGMP), regulatory guidelines, and company procedures. This role supports the lifecycle approach to validation, ensuring that equipment, utilities, facilities, computer systems, cleaning processes, and manufacturing processes are fit for purpose and meet the required standards for the production of medicinal products.

Responsibilities

• Annual revision and execution of the site validation master plan.
• The main point of contact for the delivery of the SVMP to ensure the business is on track and flag issues where there are delays.
• Lead, author and perform URS, installation, Operational and Performance Qualifications on specific projects.
• Depending on need, this may also include Process Validation, Cleaning Validation, Computerised Systems and Validation of Utilities.
• Develop and write commissioning, qualification and validation documents following either established standards and templates or improved document formats as required.
• Completing all associated project documentation in line with regulatory expectations.
• Manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports and risk assessments.
• Perform Qualification Reviews and implement remedial work.
• Review design deliverables from engineering including drawings, data sheets, specifications and engineering lists.
• Perform or coordinate P&ID walk downs and verification of system drawings.
• Ensure accurate records of all validation activities and maintain validation documentation throughout the validation lifecycle.
• Troubleshoot in the event of abnormal testing results.
• Provide the relevant support for regulatory audits, submissions and other auditor requirements.
• Communicate validation requirements across site and request support from other functions as required.
• Ensure projects are managed in conjunction with all regulatory requirements such as H&S and cGMP.

Skills and Experience Required

• Degree level qualification in relevant life science or equivalent.
• Strong communication, project management and planning skills.
• Ability to collaborate with and influence staff at all levels of the business and able to work on specific projects in a team of two or three.
• Able to implement knowledge of cGMP validation and qualification in new situations.
• Demonstrable experience of the application of cGMP requirements for validation in the EU.

Qualifications

• Strong skills in Validation and equipment qualification.
• Competence in Quality Assurance and Quality Control processes.
• Analytical Skills to evaluate data, identify trends, and troubleshoot issues.
• Excellent written and verbal Communication skills.
• Experience in a GMP-regulated environment is strongly preferred.
• Relevant degree or equivalent experience in life sciences, chemistry, or a related field.