Modis is looking for different Cqv engineers on behalf of a client.
Responsible to apply/implement Commissioning, Qualification and Validation (CQV) approach, standardized CQV procedures and provide oversight on CQV activities of capex projects . Actively contribute input/ideas to Shared Services CQV to help develop standards.
• Responsible for ensuring that projects are compliant with the global CQV guidelines, aligned with local/site level procedures and detect/resolve potential gaps in line with Lonza’s continuous improvement vision. • Provide leadership of CQV activities at Site level, acting as subject matter expert (SME) for any and all CQV activities. Support the IBEX SGIE project teams in business related quality and compliance topics, including project risk analysis.
• Leverage work being done at global level to engage specialized companies for CQV activities to support projects and yearly (re-qualification) activities . Apply applicable, globally developed Frame Agreements with local or global partners to assure adequate staffing, enhance efficiency and reduce operative costs of CQV activities.
• Track the progress of projects CQV portfolio, communicate potential issues and take leadership presenting corrective actions in an open and timely manner. Ensure all relevant stakeholders, within and outside of organization are kept informed as needed.
• Work actively with Head of Quality Assurance to support the implementation of new approaches and way-of-working in line with new manufacturing trends and concepts.
• Ensure CQV activity compliance with all pertinent safety policies, rules and regulations.
Significant experience in Commissioning, Qualification and Validation with strong experience in management of complex pharmaceutical projects
• Familiarity with biologics (mammalian, fill & finish) manufacturing technologies desirable
• Strong knowledge of ISPE and ASTM guidelines with proven experience on large and complex projects • Good understanding of how a Pharmaceutical/Bio Science business works. • Experienced in cGMP.
• Solid collaboration and influencing skills and the ability to work together with teams and individuals in a highly matrix environment
• Strong analytical skills
• Experience at working both independently and in a team-oriented environment
• Able to deal with Ambiguity - can conform to shifting priorities, and demands
• Ability to effectively prioritize and execute tasks in a fast-paced environment
• Able to develop and implement new and/or standard processes, tools/methodologies in a project contex