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.
Role Summary
The 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 control
* Periodic reviews
* Performance monitoring
* System and access administration
* Disaster recovery
* Deviations, incidents, and problem management
* Investigations and CAPAs
* Audits and policy deployment
* Cybersecurity and data integrity
* EHS compliance and training
* Uphold 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.
Experience
* Minimum
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 11
* 21 CFR Part 11
* Demonstrated 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 & Education
* Degree in
Science, Engineering, or a Technical discipline
.
* Lean Six Sigma Green Belt preferred.
* Desirable qualifications in
Project Management
and/or
Computer System Validation
.