THE ROLE
Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.
A well-established UK manufacturer of bespoke materials handling and process equipment is looking for a Technical Author to own their documentation and compliance function. This is a foundational hire - you will be building the Quality and Compliance function from scratch, with full backing from management to do it properly.
WHAT YOU'LL BE DOING
Producing technical files, user manuals, FAT/SAT protocols and regulatory submissions for bespoke equipment projects. Preparing ATEX declarations of conformity and technical files to ATEX Directive 2014/34/EU. Compiling Sistema validation documentation - strategies, protocols, test results and reports. Ensuring compliance across CE marking, PED, machinery directive, ISO standards and pharma GMP requirements. Building the compliance infrastructure from scratch - SOPs, templates, audit trails, document management and working towards ISO 9001. Reporting on quality performance to management and the board.
WHAT WE NEED
ATEX expertise is essential - technical files, declarations of conformity, categories and groups. Direct pharma project experience is essential - GMP, cleanroom standards and validation protocols. Sistema validation experience is essential. Strong technical writing skills, a solid grasp of mechanical, electrical and pneumatic systems, and a quality systems background covering ISO 9001 and audits.
THE PACKAGE
23 days holiday plus bank holidays. 3% pension. Life insurance (x3 salary). Westfield Level 1. Company sick pay. Online CPD library.
TO APPLY
Recruited exclusively by Echelon Engineers Limited. Please apply asap to avoid dissapointment. xcswzye All applications treated in strict confidence.