CSV Engineer

Title: CSV Engineer

Location: Rocky Mount, NC- Onsite

Duration: 12+ Months

You will be responsible for

• · Resolution of fundamental Computer System Validation compliance issues on assigned projects

• · Writing, reviewing, and executing computer validation documentation

• · Perform computer system validation activities related to process control systems of pharmaceutical water for injection system, water pretreatment system, water stills and high quality steam generation systems

• · Validation of computerized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ/OQ/Protocol/Report/Testing, Traceability Matrix, Validation Report)

• · Assessing electronic/paper records aiming to identify Data Integrity gaps with Risk-Based Approach in order to suggest the most appropriate mitigation/remediation actions

• · Ensuring that all project-related issues and deviations are recorded, approved and dispensed accordingly

• · Preparation of project and life‐cycle reports and review/approve all other documents to ensure compliance with SOP

• · Ensuring that all project and lifecycle documents achieve the goal of traceability, and are all retained in the document repository (Document Navigator) and approved following the prescribed SOP

About you

· At least 5 years ́s of experience in the Pharmaceuticals field, with focus on Computer System Validation

· Previous work experience in computer system validation of PLC's, HMI's, SCADA and historian.

· Experienced in computer system validation of Rockwell Factory Talk, Microsoft SQL Server, Microsoft NET Framework and Allen Bradley PLC systems preferably related to process control systems.

· Ability to perform input and output testing.

· Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and process control systems.

· Strong knowledge in good documentation practices.

· Knowledge of Data Integrity Assurance according to EU GMP Annex1, US FDA Annex 11

· Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11.)