Jobstore are recruiting on behalf of a leading Lancashire based manufacturer for a Technical Author to be responsible for producing high-quality validation, compliance, and technical documentation to support the design, manufacture, and regulatory assurance of the companys products. reporting directly to the Compliance Engineer you will; ? Prepare the required validation documentation including the Requirements Traceability Matrices, Design Qualifications, Factory Acceptance Tests, Installation and Operation Qualifications, Operator Manuals, Risk Assessment and Method Statements. ? Produce Standard Test Protocols and procedure manuals. ? Work closely with the Compliance Engineer to scope out and implement continuous improvement in the production and management of validation documentation. ? Liaise directly with other areas of the business such as the Production, Customer Care, Sales, and After Market departments on behalf of the Engineering Team. ? Work according to the applicable protocols, guidelines and legal standards as required. ? Work with our customers to understand their requirements and respond to their requests for compliance information ? Monitor and report on new and updated regulations and standards and their impacts on the companys products. What we are looking for: ? Degree qualification or equivalent, or experience in a compliance role in a similar industry. ? Knowledge of medical/pharmaceutical validation requirements is desirable ? A proven track record in the development and execution of validation protocols such as risk assessments, design qualifications, FAT, IQOQ, and Operator Manuals or similar. ? Working knowledge of CE, UKCA compliance and any associated directives; including but not limited to Low Voltage, EMF, and ATEX. ? Experience working under GMP- desirable but not essential ? Strong team player with excellent communication skills, both written and verbal. ? High attention to detail and commitment to accuracy. ? Proactive, analytical, and able to work with minimal supervision. ? Comfortable working within regulated environments. If this is the new opportunity you are looking for please click to apply now and send your CV for an immediate review.