Csv Associate Jobs

Location- New Jersey (East Hanover) (On-Site)

cell and gene therapy equipment and instruments

Ability to develop following documents:

Flaunt strong project management aptitude, coupled with the prowess to judiciously prioritize tasks.

Execute comprehensive end user testing to validate flawless execution of PQ/UAT scripts, meticulously aligned with system-level user requirements.

Provide unwavering support for audit readiness initiatives and adeptly manage internal audit processes.

Demonstrate exemplary written and verbal communication skills.

Leverage your experience in executing end user testing and meticulously documenting software-related quality events.

Collaborate seamlessly with testing and validation teams to meticulously craft validation documentation that seamlessly adheres to regulatory requisites and standards.

Experience with Alan Bradley systems such as Rockwell Automation Factory Talk, MES, PLC, SCADA. SIEMENS

Experience with Periodic CSV Review

Experience with manufacturing GMP Automation systems

No IT resource but someone who has worked in manufacturing site preferably from manufacturing background.

Periodic review of about 35 Automation systems and can be extended further to 200 odd systems.

Once onboarded will need to plan for periodic review of all the systems in scope and then start periodic review.

Authoring and executing technical commissioning and qualification documentation

System requirements and description (URS)

Maintaining clear, detailed records of qualification, and change control activities for future compliance audits.

Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls

Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:

QA CSV/ CSA senior level resource that has experience

CSV/DI Consultant that has experience with Data Integrity

Authoring and executing technical commissioning and qualification documentation

System requirements and description (URS)

Maintaining clear, detailed records of qualification, and change control activities for future compliance audits.

Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls

Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:

·System Validation Planning: Develop validation strategies and plans for our software platform, considering regulatory requirements and industry standards.

User Requirement Specification (URS): Collaborate with stakeholders to gather and document user requirements, ensuring they are accurately translated into functional specifications.

Functional Requirement Specification (FRS): Translate user requirements into detailed functional specifications that guide the design and development of our software platform.

Previous experience in computer system validation or a similar role within a regulated industry, such as pharmaceuticals, medical devices, or biotechnology.

A bachelor's or master's degree in a relevant field such as Computer Science, Engineering, or a related discipline.

Update Validation schedules matrix in Asset management software (BMRAM).

Coordinate protocol, SOP and final report approval in the electronic document management system and track the process.

Seeking recent grad, or someone with 1-2 years of experience.

Experience with: PLC Programming, PID Controller, SCADA, Ladder Logic

Prepare validation binders prior and post- qualification protocol execution.

Execute and/or review qualification protocols with guidance as needed.