LabAnswer is the leading and largest laboratory informatics consultancy; combining science, laboratory, regulatory and information technologies. We have the people, processes, methodologies, IP and experience to deliver comprehensive laboratory informatics solutions.

LabAnswer has architected, implemented, deployed and/or supported hundreds of major scientific informatics systems across more than a thousand laboratories. LabAnswer performs significant laboratory automation work in pharmaceuticals, bio-pharmaceuticals, medical devices, forensics, and life sciences research laboratories spanning research, development and manufacturing/QC operations.

The LabAnswer team has a rare combination of laboratory science, IT, business and regulatory expertise. We specialize in helping companies strategize, architect, implement and support scientific data management and laboratory automation projects.

The Laboratory Systems Validation Specialist 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.   This position is based in the San Francisco Bay area so travel is limited if you are residing in this location.

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

• LabWare LIMS validation experience

• 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

Education:

Bachelor Degree in chemistry or related discipline or related experience

At LabAnswer we offer a very competitive
compensation package based on experience and education. We are looking for
excellent people to join our team, those who are looking to join a company for
the long term. Our consultants are team players and are the best at what they
do. Please read our employee value proposition and philosophy statement at www.labanswer.com to see if you are the right match for LabAnswer