CSV Analyst
Contract W2
Hybrid
$40 - $50/hr
Fitment
Dice Job Match Score™
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Job Details
Skills
- Rockwell
- Manufacturing Systems
- CSV
Summary
Job Title- CSV Analyst
Job Location- WestPoint, PA (Hybrid, 3 days/week need to be on site)
Mandatory Skills- CSV ( Manufacturing Systems- DeltaV,Rockwell,MES,PI etc),KNEAT,MEDS Job Description- Hands-on experience supporting validation and compliance activities for computerized manufacture
ng systems in a regulated pharmaceutical environment.
- Provide CSV compliance support for Capital and Strategic Projects to ensure continuity of compliance oversight and project delivery.
- Develop, review, and approve validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.
- Provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, and change control processes.
- Strong experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical/manufacturing environments.
- Knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA, and Risk Management.
- Experience reviewing and approving validation documentation and compliance deliverables.
- Familiarity with GxP regulations, Data Integrity, FDA, EMA, and industry compliance requirements. Exposure to one or more manufacturing automation platforms including:
- DeltaV DCS
- PLC systems (Rockwell and/or Siemens)
- Process Historians
- Laboratory Automation Systems
- Experience with validation, qualification, change control, risk assessments, and lifecycle compliance activities associated with manufacturing and laboratory computerized systems.
Understanding of GxP, Data Integrity, CSV/CSA, and SDLC requirements for manufacturing automation platforms
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: intelsft
- Position Id: 9093804
- Posted 1 day ago
Company Info
About Intellisoft Technologies
Intellisoft partners with organizations to provide end-to-end technological solutions since 1997. Our corporate headquarters is based in Dallas, TX. In addition to our US locations, we have offices in Europe and Asia. We serve small to mid-size companies, as well as large and Fortune 500 corporations. Our team of consultants and engineers deliver trustworthy and reliable software solutions to our Clients to increase their sales and profitability.
Our highest compliment is that our Clients recommend and refer our services for any and everything software related on a consistent bases over the almost 20 years. The Intellisoft team distinguishes itself by developing and implementing innovative technology products. Our experience allows us to analyze existing technology environments, customize based our Clients organizational needs and goals, deliver operating systems and application programming and ensure full integration into the existing environments.
Mission:
The Intellisoft team is fiercely dedicated to delivering results-oriented services to our Clients. Our team of experts demonstrates the values that make our company reliable and dependable to provide meaningful solutions. All our offices are integrated to form a unique combination of skills and expertise in order to provide the best service.
Our Services:
Our services include but are not limited to the following areas;
Our highest compliment is that our Clients recommend and refer our services for any and everything software related on a consistent bases over the almost 20 years. The Intellisoft team distinguishes itself by developing and implementing innovative technology products. Our experience allows us to analyze existing technology environments, customize based our Clients organizational needs and goals, deliver operating systems and application programming and ensure full integration into the existing environments.
Mission:
The Intellisoft team is fiercely dedicated to delivering results-oriented services to our Clients. Our team of experts demonstrates the values that make our company reliable and dependable to provide meaningful solutions. All our offices are integrated to form a unique combination of skills and expertise in order to provide the best service.
Our Services:
Our services include but are not limited to the following areas;
- Staffing & Recruiting
- Consulting & Support
- Infrastructure Management
- Outsourcing
- VoIP Support & Consulting
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