Computer Software Validation from Entry Level to Management

Computer Software Validation from Entry Level to ManagementCambridge, MA
About us-
CSSC Inc. www.csscinc.net focuses on Regulatory Compliance and Validation Services for the Lifescience industry, and has a particular focus on large scale validation projects such as enterprise system implementation and validation. We are the recognized leader in the Validation Services for the Life Science industries since 1994. We have six U.S. offices serving Metropolitan Boston, New York/ New Jersey, RTP, Chicago, San Diego and Atlanta.
We are growing!! As a result we currently have multiple openings:Computer Systems Validation Engineer
Senior Computer Systems Validation Specialist
Validation Project ManagerCSSC is focused on the delivery of high quality, validated solutions on time and on budget. Due to our success, we need talented, results-oriented Validation professionals to participate in and steer our validation projects. The growth is mainly in large scale Enterprise Applications in the area of ERP, CDMS, AERS, LIMS, CRM and EDMS implementation and validation. In addition, we do a fair amount of SOP development, 21 CFR Part 11 Assessments, Gap Analysis, Remediation Planning, Training, Equipment and Process Qualifications, and Implementation Project Management. CSSC is usually chosen for large scale validation and implementation projects due to our strong commitment to Project Management and Quality Assurance.The Job-
•Computer Systems Validation Engineer - you will be expected to capture User Requirements, map them to Functionality in applications, capture the design specifications and write and execute various Qualification protocols.
•Sr. Computer Systems Validation Specialist - you will be expected to be able to advise on compliance to various FDA regulations, conduct all aspects of validation projects with little guidance, and conduct quality assessments / audits.
•Validation Project Manager - you will be expected to manage all aspects of the project engagements, including staff. In addition, you would be developing Compliance and Validation documentation including SOPs, Plans, Requirements, Qualifications and Reports.
Each role affords the opportunity to interact with all levels of management and our clients, and affords you the exposure to the latest technologies. You will be expected to develop a strong skill base by which we fulfill our contractual obligations to clients. We encourage employee involvement and professional development.Benefits-
CSSC provides substantial health care benefits, group term life insurance, 401K plan with Match, a generous Paid Time Off allowance, paid parking, and when applicable expense reimbursement for our full-time employees.
REQUIREMENTS
Qualifications-
•Undergraduate degree in a relevant discipline.
•Excellent written and oral communication skills to interface effectively with clients
•Two to six years relevant experience with validation of systems depending on role
•Experience at Pharmaceutical, Biotech, CRO or Medical Device Firms•Good understanding of Validation principles.
•Flexibility to travel if required.To Apply –
For more information and to respond to this opportunity, please go to: http://www.MyChoiceEngine.com/Role/26768.EOE