CSV Specialist

Job Title: CSV Specialist
Address the work will be performed: Metro Detroit area, Michigan
Target start date: 10/10 or 10/17
Length of contract assignment: 6-months to start- chance of extension or possibly converting if the workload if consistent

Work schedule/typical work week/daily start and end time:
• M-F 8-4
• On-site daily for first month, after training and knowing systems/teams than a hybrid schedule is ok
Client description:
• Mid-sized CDMO that has a few areas of focus (Oral Solids, Sterile Injectables, Peptides, Patent APIs, and Antibody Drug Conjugation).
Project description:
Our client needs a strong CSV Specialist to join their IT team. You will work alongside IT and support QC, QA, and Operations on GxP computer systems (mainly lab systems using OpenLab CDS). You will also play a key role on the SOP standardization project. Right now, this site is already in process of reviewing
& revising SOPs, but they need additional support on working with other sites to help standardize their SOP’s across all locations. You will assist with authoring and revising SOPs, as well as conducting risk assessments and gap assessments of the documents.

Technology environment the consultant will be working in:
MasterControl, Nsure, Trackwise, ValGenesis Consultants day to day responsibilities:
• Part of the IT team, you will work with cross functional teams such as QC, QA, and Operations.
Daily responsibilities include:
o Author, Review, and Revise SOPs (perform Risk Assessments and Gap Assessments as needed)
o Prepare Master Validation plans, validation/qualification protocols and reports to ensure compliance with SOPs
o Support validation on GxP computerized systems to ensure compliance to meet cGMP standards and 21 CFR Part 11
o Ensure all CSV and GMP related issues and deviations are recorded, investigated, and approved accordingly
o Monitor data backup, data integrity, and disaster recovery
Required Skills:
• CSV experience working in a GMP regulated Biotech/Pharma environment
• Prior experience performing validation on lab equipment in a GxP 21 CFR Part 11/Annex 11 environment
• Experience working with an eDMS (preferably Master Control)
• Must be vaccinated
Desired Skills:
• OpenLab CDS experience
• Self starter, willingness to take ownership of a project or initiative

Job Title: CSV Specialist
Address the work will be performed: Metro Detroit area, Michigan
Target start date: 10/10 or 10/17
Length of contract assignment: 6-months to start- chance of extension or possibly converting if the workload if consistent

Work schedule/typical work week/daily start and end time:
• M-F 8-4
• On-site daily for first month, after training and knowing systems/teams than a hybrid schedule is ok
Client description:
• Mid-sized CDMO that has a few areas of focus (Oral Solids, Sterile Injectables, Peptides, Patent APIs, and Antibody Drug Conjugation).
Project description:
Our client needs a strong CSV Specialist to join their IT team. You will work alongside IT and support QC, QA, and Operations on GxP computer systems (mainly lab systems using OpenLab CDS). You will also play a key role on the SOP standardization project. Right now, this site is already in process of reviewing
& revising SOPs, but they need additional support on working with other sites to help standardize their SOP’s across all locations. You will assist with authoring and revising SOPs, as well as conducting risk assessments and gap assessments of the documents.

Technology environment the consultant will be working in:
MasterControl, Nsure, Trackwise, ValGenesis Consultants day to day responsibilities:
• Part of the IT team, you will work with cross functional teams such as QC, QA, and Operations.
Daily responsibilities include:
o Author, Review, and Revise SOPs (perform Risk Assessments and Gap Assessments as needed)
o Prepare Master Validation plans, validation/qualification protocols and reports to ensure compliance with SOPs
o Support validation on GxP computerized systems to ensure compliance to meet cGMP standards and 21 CFR Part 11
o Ensure all CSV and GMP related issues and deviations are recorded, investigated, and approved accordingly
o Monitor data backup, data integrity, and disaster recovery
Required Skills:
• CSV experience working in a GMP regulated Biotech/Pharma environment
• Prior experience performing validation on lab equipment in a GxP 21 CFR Part 11/Annex 11 environment
• Experience working with an eDMS (preferably Master Control)
• Must be vaccinated
Desired Skills:
• OpenLab CDS experience
• Self starter, willingness to take ownership of a project or initiative