If you’re passionate about turning complex requirements into elegant, validated systems—and you thrive in a collaborative, matrixed environment—this role is your opportunity to make a visible impact on tech transfer timelines, batch right‑first‑time performance, and regulatory readiness. | Why you’ll love it here | - Shape how development knowledge (DoE, QbD) flows into manufacturing execution and CPV | - Own high‑value platforms with direct line of sight to business outcomes | - Partner across PD, MSAT, Automation/Engineering, QA/Validation, and IT/OT | - Drive standardization at scale with class‑based, globally reusable configurations | - Operate with autonomy while influencing best practices across sites | What you’ll do | - Design, configure, implement, and maintain PDLM, ELN, and Risk Management platforms to meet user and compliance requirements | - Translate business needs into scalable, class‑based configurations and reusable library objects that enable data standardization | - Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on risk‑based validation (GAMP 5, CSA) and audit readiness | - Define and enforce standards, templates, libraries, and master data structures in partnership with Master Data teams | - Deploy class‑based data structures to deliver recipe data models and master data (materials, specs, equipment classes) | - Develop training, job aids, and adoption materials; coach teams on ISA‑88 and digital recipe best practices | - Manage external partners and solution vendors; define user requirements, participate in design reviews, and ensure delivery to standards and timelines | - Contribute to digital thread initiatives linking development knowledge to manufacturing execution and CPV; support regulatory inspections and filings | - Drive harmonization and standard work across sites (templates, test protocols, UAT scripts) to reduce cycle times and deviations | - Champion continuous improvement through metrics, KPIs, and standardized ways of working | What success looks like | - Seamless, compliant platforms that accelerate development and tech transfer | - Standardized data models and libraries that scale globally | - Strong adoption and user satisfaction through clear training and enablement | - Audit‑ready documentation and validated configurations | - Reduced cycle times, deviations, and rework through harmonized processes
- Responsible for the maintenance, repair and compliance of the site services equipment and utilities | - Responsible for managing own safe working behaviour, demonstrating a high regard for personal EHS performance, sustaining a zero overdue status of assigned investigations and actions. | - Meet the site target of zero overdue compliance actions in terms of Quality actions and documentation updates. | - Act as first point of technical support to the maintenance team for all aspects of the site services systems and equipment. Work closely with the maintenance and planning teams to deliver site availability targets. | - Contribute to all Root cause analysis investigations and implementation of long term engineering solutions to prevent reoccurrence. | - Up hold technical standards to assure the assets remain fully compliant with GMP status. | - Liaise with contractors to assure technical compliance of all works, ability to review risk assessments and perform isolations as required. Write and accept permit to work, willingness to support maintenance team in all activities including trade tasks if required. | - Support site services technical planning for the site annual shutdown.