We are looking for a Computer Systems Validation Engineer with experience in computer systems validation work with preference to those familiar with MODA and/or LabWare interfaces. Technical duties include developing and implementing validation protocols, adhering to domestic and international GMP regulations. It also includes communicating with impact, operating collaboratively while holding themselves and other team members accountable and proactively taking steps to learn & grow based on feedback. The individual will collaborate with cross-functional team members such as Quality Systems, Quality Control, Project management and other technical disciplines to lead execution of assigned validation deliverables of the projects.
Experience essentials:
Bachelor’s degree in a technical discipline, preferably engineering or biological sciences and a minimum of 5 years pharmaceutical and/or biopharmaceutical industry experience. Corresponding relevant experience in lieu of a bachelor's degree will be considered when assessing candidates.
Understanding, adhering to and maintaining compliance with cGMP standards is fundamental. Position will navigate complex regulatory requirements to ensure that all changes to LIMS/MODA systems meet industry standards.
Thorough understanding of cGXPs, GAMP5, S88 and 21CFR Part 11 (as applicable).
In-depth knowledge of core principles of validation programs.
Experience in Trackwise, Veeva, Kneat, ALM or other common electronic documentation systems.
Numbers & Facts
Location
Lexington, MA
Industry
Staffing/Employment Agencies
Company Size
500 to 999 employees
Website
https://www.thefountaingroup.com/
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
Skills
Bioengineeringunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Code of Federal Regulationsunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
GCP (Good Clinical Practices)unmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Industry Standardsunmatched
Laboratory Information Management System (LIMS)unmatched
Labwareunmatched
Maintain Complianceunmatched
Project/Program Managementunmatched
Quality Controlunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
System Validationunmatched
Systems Engineeringunmatched
Validation Planunmatched
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