CVS Analyst

Noblesoft Technologies Inc.; Parker Ford (PA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Noblesoft Technologies Inc. is seeking a CSV Analyst in WestPoint, PA. This hybrid role requires on-site presence 3 days a week and focuses on validation and compliance for computerized manufacturing systems in a regulated pharmaceutical environment.

You will develop and review validation artifacts, provide CS&A guidance to project teams, and ensure adherence to GxP, FDA/EMA expectations, and data integrity across SDLC processes.

Qualifications

• Hands-on CSV validation/compliance support in regulated pharma.
• Experience with validation lifecycle deliverables (IQ/OQ/PQ) and CSA.
• Knowledge of SDLC, GxP, Data Integrity, change control, and risk management.

Responsibilities

• Support validation and compliance activities for computerized manufacturing systems.
• Develop, review, and approve validation lifecycle deliverables per GxP and SOPs.
• Provide compliance guidance to project teams on SDLC, CSA, and qualification processes.
• Review validation documentation and ensure data integrity and regulatory compliance.

Skills

CSV

DeltaV

Rockwell

MES

PI

KNEAT

MEDS

Tools

DeltaV DCS

Rockwell PLC

Siemens PLC

Process Historians

Laboratory Automation Systems

Job description

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 manufacturing 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.