A strongScientific and technologicalpioneering spirit drivesbioMérieuxdevelopment since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioMérieux commitment to public health.
bioMérieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products.
We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.
Primary Purpose and Overall Objective of the Job: Develops, supports and implements non-product software verification & validation projects and initiatives within the Global IS Department, into the Quality, Validation and Testing Team, as defined below.
Under the responsibility of the Verification & Validation Global Manager (located in France), Responsibilities includes:
- Support IS and business teams with developing and delivering validated tools, compliant platforms and solutions.
- Contribute toward the development of a customer focus and collaborative attitude with V&V team as well as with project members and stakeholders. Ensure that internal customer requirements and expectations have been accurately identified.
- Ensure that all project participants (project manager, business analyst, developer, business representative) are accountable for their part of the V & V activities and V & V inputs.
- Ensure compliance of V & V process, activities and records and be accountable in front of third party audits and inspections and enforce implementation of good quality practices (documentation, traceability, record, inspection readiness) within V & V organization
- Share and implement best practices coming from other global function, industry and benchmark.
- Ensures schedules are executed on time, project costs are respected and required compliance levels are achieved.
- Manage risk, produce verification and validation plans, protocols, and reports; lead the execution of the plans and protocols, and manage deviations.
- Support change control processes in support of system changes. Provide change control training as requested.
- Support supplier and internal audit initiatives related to verification & validation activities.
Skills and Qualifications
- Bachelor’s Degree or equivalent in a life science or engineering discipline with > 8-year work experience as a V&V Engineer in the Health Care related industry.
- Experience in the management of regulatory audits (i.e. FDA, ISO,…) and knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, GAMP5, 21CFR11, Computer System Validation, etc.).
- Significant experience with validation and verification testing techniques and methodologies
- Experience in software lifecycle management
- Excellent interpersonal and communication skills and good problem solving skills enabling the individual to establish a high level of credibility to positively influence activities.
- Significant experience within or in partnership with technical, business and quality management personnel
- Strong customer orientation
- Personal qualities of enthusiasm, determination, patience and leadership are required to influence the outcomes of stakeholders such as senior management, customer, colleagues.
- Solution orientated attitude.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity
May 7, 2018, 7:16:35 PM
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