CSV Migration Consultant
CSV Migration Consultant
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Salary Not Disclosed
1 Vacancy
Job Description
- Our client is seeking an experienced CSV Migration Consultant to support the implementation migration and validation of critical manufacturing systems within a regulated environment.
- This role requires deep expertise in automation and computerized system validation particularly with Rockwell and Pharma Suite platforms.
- The ideal candidate will have a strong background in the full CSV lifecycle regulatory compliance and the ability to work in both independent and collaborative settings.
- Lead the implementation migration and validation of computerized systems including PCS (Rockwell/Client) MES (Pharma Suite POMSnet) and SCADA/PLCs.
- Apply hands-on expertise in programming commissioning and validating Rockwell and Pharma Suite platforms.
- Author review approve and execute CSV lifecycle documentation in compliance with applicable procedures and industry standards.
- Ensure adherence to SDLC principles and regulatory requirements including 21 CFR Part 11 Annex 11 GAMP 5 and Data Integrity guidelines.
- Manage document and assess software changes throughout the SDLC.
- Collaborate with cross-functional teams to ensure seamless integration and operational excellence.
- Utilize knowledge of S88 Batch Standard for batch process design.
- Perform MES recipe authoring and testing as well as Rockwell software object development.
- Support system validation activities using Kneat.
- Experience supporting medium-to-large-scale capital projects in a procurement or expediting function.
- 12 years of CSV/Automation experience in a regulated environment.
- Strong hands-on experience with Rockwell and Pharma Suite (required).
- Proven track record in implementing and validating PCS MES SCADA and PLC systems.
- In-depth knowledge of SDLC 21 CFR Part 11/Annex 11 Data Integrity and GAMP 5 guidelines.
- Experience with software change management and documentation practices.
- Familiarity with S88 Batch Standard Rockwell software object development and MES recipe authoring/testing is preferred.
- Experience with Kneat or other validation management tools is preferred.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively within a team-oriented environment.
Employment Type
Full-time
