Company Description
Milestone, a division of the global PM Group, provides advanced automation and digital systems consultancy services, specializing in Life Sciences and FMCG sectors. With a team of over 160 experts, we bring a comprehensive perspective to project implementation through our experience as end users, engineering consultants, and system integrators. Our service offerings include digital factory delivery, system integration, compliance, and manufacturing intelligence among others, ensuring tailored solutions for business needs. As part of the employee-owned PM Group, which operates in Europe, the UK, USA, and Asia, Milestone combines decades of expertise with a commitment to optimizing client outcomes.
We are seeking an experienced
Technical Writer
to support a pharmaceutical client on a project within a start-up manufacturing facility. The successful candidate will have strong
MES (Manufacturing Execution System) documentation experience
and a solid understanding of GMP environments.
Key Responsibilities:
* Author, review, and update GMP documentation including
SOPs, work instructions, and MES-related documents
* Support
deviations, change controls, and CAPAs
, ensuring accurate and compliant documentation
* Collaborate with Quality, Manufacturing, and MES teams to ensure documentation aligns with site and regulatory requirements
* Support documentation readiness for audits and inspections
* Ensure documentation reflects start-up facility processes and evolving systems
Requirements:
* 3+ years' experience
in a Technical Writing role within the
pharmaceutical or biotech industry
* Strong experience with
MES documentation
in a GMP-regulated environment
* Proven experience authoring
SOPs
, and supporting
deviations and change controls
* Experience working in a
start-up or greenfield facility
is highly desirable
* Knowledge of EU GMP and regulatory standards
* Excellent written communication and stakeholder engagement skills