Website Asset Recruitment
• 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
The candidate should have a strong understanding of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations.
• 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
• 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
o Lean/Six sigma belt certification/experience