LabAnswer is the leading laboratory informatics consultancy in North America. We work with “best in breed” Laboratory Informatics software products to provide total solutions for our biotech and pharmaceutical clients. LabAnswer is expert in architecting, configuring, deploying, validating and supporting laboratory systems. These systems include LIMS, CDS, Scientific Content Management Systems and Electronic Lab Notebooks.

As a LabAnswer consultant you will be exposed to the technologies and processes that many leading US companies utilize. We offer a generous compensation package consisting of salary, bonuses and benefits. Our customers are located all over the US, which means you need to plan to travel at least 50% of the time. Our consultants can live in any city with a major airport and access to broadband services. In addition you can work from home when you are not traveling.

This position will be responsible for defining validation requirements, developing systems validation documentation, generating and executing test protocols and summarizing validation activities in reports. The selected individual will play a key role throughout the system development life cycle (SDLC), from validation of complete new systems on projects through qualification of changes for existing systems, to assure that all critical systems remain in a validated state. Their focus will be on computerized systems in support of the Pharmaceutical, Biotechnology and Medical Device industries, including but not limited to manufacturing, laboratory and clinical applications as well as business systems.

Responsibilities (including but not limited to):

• Assists in the management of computer systems validation
• Assists in defining validation strategy
• Qualification / validation of automated test management tools, specifically Mercury TestDirector for Quality Center and QuickTest Professional
• Generation of validation documentation, which include validation plans, audit plans, requirement specifications, test plans, IQ, OQ and PQ protocols, test cases/scripts, traceability matrices and validation reports
• Development and execution of functional testing. Both manual and automated
• Conducting risk assessments and periodic audits of systems and software development activities
• Ensures all systems and software are in compliance with GMP, GLP, GCP, QSR, 21 CFR Part 11, ICH guidelines, and GAMP guidelines
• Assists in the management of controlled documents
• Responsible for training related to validation projects, client-specific software applications and SOPs
• Development of SOPs in support of quality systems and software development

Minimum Requirements (education and work experience):

• BS or MS in computer science, life sciences, engineering or equivalent work experience with 2 - 5 years validation experience in the biotechnology, pharmaceutical or medical device industries
• Working knowledge of GMP, GLP, GCP, QSR, GAMP and 21 CFR Part 11 as they relate to computer systems validation
• Knowledgeable in applying SOPs, work instructions and regulatory requirements to the System Development Life Cycle
• Experience with testing and supporting manufacturing, laboratory and clinical applications as well as business systems is helpful. (i.e. MES, PLC, SCADA, LIMS, CDAS, CDMS, EDC, CTMS, SAP)
• Experience with Client Server, RDMS Database ( Oracle, Sql server, etc), and Web applications
• Experience in software development life cycle for computer systems
• Excellent written and verbal communication skills, with hands-on experience working in a systems development environment, and as a productive and supportive member of a multidisciplinary project team