Position:CSV Migration Consultant
Location:Vacaville, CA (Onsite)
Length:12 months
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 PharmaSuite 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.
Essential Duties and Responsibilities (but not limited to):
- Lead the implementation, migration, and validation of computerized systems, including PCS (Rockwell/Honeywell), MES (PharmaSuite, POMSnet), and SCADA/PLCs.
- Apply hands-on expertise in programming, commissioning, and validating Rockwell and PharmaSuite 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.
Qualifications:
- 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 PharmaSuite (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.
- Pay rate $90.00/hour depending on experience.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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Digital Prospectors
Aug 16, 2025