This is an 11 month contract role.
• Work with Process Design Managers in the development of Regulatory Design Basis and C&Q Execution Strategy during Concept and Basis of Design phases of projects.
• Support project teams in assessing project level staffing needs to ensure that appropriate C&Q staffing, expertise and leadership (both with internal and external resources) exists to successfully execute projects.
• Facilitate GMP design reviews, design qualification and collaborate on the development of Project Validation Master Plans and execution of Product Quality Risk Assessments.
• Provide direct project support for strategic and at risk projects to ensure successful execution of the C&Q strategy.
• Participate in project assessments for active projects to identify opportunities for improvement and confirm readiness for project to progress through the stagegate process.
• Acts as a subject matter expert on: regulatory compliance in facility and equipment design and qualification; C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. and requirements traceability matrices, Construction QA/QC, Turnover Pack compilation, Document Mgt. Systems, FAT/SAT and C&Q protocol development.
• Participate in the implementation of digital/paperless C&Q execution.
• Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into the C&Q value stream.
• Facilitate C&Q peer reviews across projects to mitigate against unintended omissions/gaps in strategy and execution plans.
• Through use of leading indicator/KPI’s and regular assessments of critical to C&Q project deliverable progress, ensure right first time delivery for the C&Q phase.
• Ensure adherence to Quality Manual guidelines & GES Practices and Procedures.
• BS Degree in Chemical/Mechanical Engineering, Biotechnology or equivalent applied life sciences qualifications.
• Extensive C&Q experience, including a C&Q leadership role on a significant large capital project in the Pharmaceutical / Biotech Industry.
• Experience in Drug Substance, Drug Product, and clean and black utility systems.
• Experience staffing and managing contract personnel on a project team basis.
• Demonstrated knowledge of ISPE Baseline Guide 5; ASTM E-2500; FDA, EU regulatory requirements.
• A strong understanding of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations.
• Teaching, training and coaching of internal colleagues and partner resources.
• Change management – sponsor an end to end mindset – successful capital project delivery is a key enabler to a successful start-up in realizing on-time, reliable and compliant product supply.
• Passion for instilling a proactive safety, environmental and regulatory compliance culture.
• Post-OQ/Tech Transfer phase – Clean Utility, HVAC/environmental and Process PQ’s; cleaning, thermal cycle development and validation; demonstration batch manufacture; operational readiness and maintenance readiness workstreams.
• Experience with digital/paperless validation.
• Prior project management knowledge.
• ISPE GAMP 5 – Risk Based approach to compliant GxP Computer Systems.
• Lean/Six sigma belt certification/experience.
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