Job Title: SYSTEMSENGINEER
Job Location: BostonMA(HybridThree days onsite with two days Remote)
Job Duration: LongTerm
JobDescription:
REQUIREMENTS:
* MUST HAVE SOP Documentations GENERATIONexperience!
* 8 or more years of SystemsEngineering experience with a degree in bio tech or computerscience.
* Technical writing building SOPS GXPIT programs
* Knowledge of GAMP regulations andPart 11 3.
* Must have worked in GXP QC LabEnvironment
* Minimum 4 years experience withinthe Biotech/Pharma industry
* A minimum of 4years hands on technical experience supporting IT systems includingWindows Server Active Directory LDAP SQL databases terminal serversdata backup utilities etc.
* Experience with labsystems including HPLC UPLC Mass Spec UVVis and FTIR from differentmanufacturers (Thermo Fisher Agilent Novasep Gilsonetc.).
* Good understanding of computer systemsmanagement in cGMP operations.
* Anunderstanding of GAMP 5 21 CFR Part 11 Annex 11 and other industrybest practices is required.
*
Preferred Knowledge andExperience:
* EQMS (Veevaetc)
* Lab Software (Thermo Agilent Watersetc.)
* Backup and Recovery Tools (Acronisetc.)
* Windows Server
* Active Directory
* SQL
* Terminal Servers
* OSPatching