QAIT Specialist Shopfloor Systems

The successful candidate will join the QA IT team to provide independent compliance oversight and support for the implementation of new shopfloor automation systems and modifications to existing site systems.  The QA IT specialist will ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity […]

Quality Assurance Validation Specialist

Responsibilities   Act as Quality Assurance approver for qualification/validation lifecycle documents. Serve as a quality assurance resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities. Provide Quality Assurance Validation support for Steam In Place (SIP) of buffer and media preparation systems, upstream (bioreactors) and downstream […]

CSV Engineer

Generate/ update, execute, review and approve Computer System Validation (CSV) documentation deliverables as part of a multi-disciplinary team of site representatives responsible Process Automation Remediation Plan delivery.     Responsibilities   Generate/ update, execute, review and approve Computer System Validation (CSV) deliverables in line with the Process Automation Remediation Plan delivery. Investigate and trouble shoot […]

Automation Engineer

Reporting to the site DeltaV Lead, supporting delivery of DeltaV scope on the project(s). This candidate will be required to work closely with the site teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.     Responsibilities   Develop and review System Development Life […]

Project Manager

Responsibilities   Managing delivery of Project deliverables, the consistency, visualization and management of the project execution through effective communication plans and stakeholder management via the Governance Process. Engage and work collaboratively across site teams to ensure the projects are successfully deployed. Report to the Site Project Management Office Lead. Manage the portfolio of Projects in […]

Quality Assurance Specialist

Provide Quality oversight on the design and qualification activities as part of the design, construction, qualification and start-up of the new facility.   Responsibilities   Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations. Quality SME for the execution and reporting phases of the qualification and validation activities […]

Quality Assurance – IT

Generate/ update, execute, review and approve CSV documentation deliverables as part of a multi-disciplinary team of the site representatives responsible for Analytical Instrument Qualification (AIQ) Alignment/Remediation Plan delivery.   Responsibilities   Execution/Review/Approval of test protocols using the Kneat system. Assess existing validation testing to ensure compliance to internal Quality Standards and expectations. Investigate, raise, review, […]

Automation Engineer

Responsibilities   Reporting to the Engineering Manager, this is a key role supporting the Site Automations systems including the Manufacturing Network, BMS/EMS, SCADA and process equipment PLCs/IPCs/HMIs. Responsible for day-to-day operations support activities including problem solving, develop short- and long-term solutions for automation problems, validating computer equipment, maintaining current systems in a GMP state and […]

Automation Engineer

Responsibilities   Reporting to the Automation Lead, responsible as Automation SME for project to re-write Automation Specification to site standard and analyse and close any resulting gaps Work closely with the Automation dept & the CSV team responsible for the project Develop and/or review SDLC deliverables, compliant with site standards, including but not limited to: […]

Technical Support Analyst

Responsibilities   Assists all corporate and remote users with technical issues related to hardware, software and connectivity issues. Runs diagnostic programs, isolates problems and determines and implements solutions. May provide desk side or remote assistance. Determines when to escalate unresolved issues to the appropriate IT team for further support. May serve as point of escalation […]