CSV Engineer

3 weeks ago

South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full time

Roles & Responsibilities:


Authors, executes and/or reviews validation documents such as validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA and validation exceptions/deviations for Computer and IT systems.

Expertise in MES/Delta-V/LIMS/Lab Equipment and Manufacturing CSV systems.

Schedules and executes validations per ASTM, GAMP V, standard operating procedures and regulatory guidelines.

Lead assigned validation related investigations and conduct data integrity (DI) assessments with DI remediation planning.

Champion and lead continuous improvement efforts on every aspect of validation


Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.

Foster cross-departmental relationships (QC, Materials Management, IT, Manufacturing, QA and site leadership) by representing Validation at team meetings.

Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.


Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.

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