Position: CSV Lead
Duration: 6+ months contract
Location: Bloomington, IN
Job Description:
We are a mid-sized BioPharma organization looking for a Computer Systems Validation specialist with:
A minimum of 10 years hands on CSV experience that is an expert in assuring compliant computer systems throughout the software development lifecycle, validation, maintenance, and decommissioning.
Hands on skills and experience of data migration planning, testing and reporting.
Strong working knowledge of data integrity requirements, controls, execution, evidence and reporting.
Comfortable and knowledgeable in the execution of infrastructure qualification.
A minimum of 10 years supporting regulatory inspections such as FDA, EMA inspections
Experienced in leading CSV approaches for individual projects.
Experienced in leading technical conversations re the CSV approach and content for specific validation deliverables.
Educating and mentoring IT staff with minimal GxP knowledge and experience.
The Role:
To own and lead CSV thinking and specific execution approaches in all software areas, ERP, data warehousing, laboratories and manufacturing areas.
To own and lead CSV CoE, (Centre of Excellence) and CoP (Community of Practice). The purpose of these forums being:
- CoE: Deliver and maintain a world class QMS for CSV & Data Integrity. Policies, Standards, SOP, templates, risk-based approach, CSA, etc.
- CoP: Create and maintain a world class team of various SMEs that use or rely on CSV practices, educating and supporting CoP team members from the CIO to the Lab SME or manufacturing supervisor.
Provide CSV SME leadership as required to project implementation teams or IT staff maintaining GxP applications.
Develop and build compliance framework and dashboard to proactively monitor compliance and act as required to assure compliance.
Role Details:
- Frequent visit to sites shall be required.
- Reports to Director of CSV and QMS.
- Technical leadership role requiring strong general GMP and QMS knowledge.
- Supporting CSV projects, communication and building of teams will be primary aspects of the role.
Required Skillset
• CSV Expert 10+ years
Proven Technical Leadership Skills
- Recent Biopharmaceutical Industry Experience
- FDA / EMA Inspection Readiness
Thanks,
Raja
