Company DescriptionMilestone, 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.Role SummaryThe Compliance Engineer will support Compliance activities within a single-use, multi-product biotechnology manufacturing facility. The role focuses on maintaining inspection readiness, ensuring adherence to regulatory and internal compliance requirements, and supporting the delivery of high-quality products in a regulated environment.Role Functions(Functions include, but are not limited to, the following)Ensure continuous inspection readiness within the compliance team.Support the generation, review, and approval of CSA/CSV deliverables .Provide ongoing compliance coaching and support to team members across GxP, financial, and data privacy requirements.Manage the deployment of global SDLC/CSA and IT security policies and procedures .Ensure availability and execution of all compliance components required to deliver high-quality product through effective planning and execution of project and operational compliance activities, including:Change controlPeriodic reviewsPerformance monitoringSystem and access administrationDisaster recoveryDeviations, incidents, and problem managementInvestigations and CAPAsAudits and policy deploymentCybersecurity and data integrityEHS compliance and trainingUphold the highest standards of Quality, EHS, and Compliance .Actively participate in tiered governance processes and proactively resolve issues.Liaise with compliance engineers and stakeholders across functional areas to support site-wide quality initiatives and governance forums.Coordinate change controls, EHS activities, and EHS/Quality metrics related to automation and IT systems.Complete investigations, perform root-cause analysis, and implement effective CAPAs.Apply strong project management skills to support project delivery and operational readiness.ExperienceMinimum 2 years' experience in planning, documentation, support, or execution of computer system validation (CSV/CSA) activities within a biologics or regulated manufacturing environment.Strong working knowledge of regulatory requirements for computerized systems, including:EU GMP Annex 1121 CFR Part 11Demonstrated expertise in Data Integrity, including familiarity with industry guidance such as MHRA and PIC/S data integrity principles.Experience with PLC, SCADA, and/or DCS systems .Strong collaboration, communication, and compliance mindset.Qualifications & EducationDegree in Science, Engineering, or a Technical discipline .Lean Six Sigma Green Belt preferred.Desirable qualifications in Project Management and/or Computer System Validation .