Validation Expert with LIMS

4 days ago


Seattle, Washington, United States Futran Tech Solutions Pvt. Ltd. Full time
Job Title: Validation Specialist with LIMS

Futran Tech Solutions Pvt. Ltd. is seeking a highly skilled Validation Specialist with expertise in LIMS and MES systems to join our team.

Job Summary:

We are looking for a talented individual to lead validation-related investigations, conduct data integrity assessments, and champion continuous improvement efforts in validation. The successful candidate will have expertise in MES/Delta-V/LIMS/Lab Equipment and Manufacturing CSV systems, and will be responsible for scheduling and executing validations per ASTM, GAMP V, standard operating procedures, and regulatory guidelines.

Key Responsibilities:
  1. 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.
  2. 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.
  3. Lead assigned validation-related investigations and conduct data integrity (DI) assessments with DI remediation planning.
  4. Champion and lead continuous improvement efforts on every aspect of validation.
  5. 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.
  6. Foster cross-departmental relationships (QC, Materials Management, IT, Manufacturing, QA, and site leadership) by representing Validation at team meetings.
  7. Employ good document practices (GDP) when recording data, maintaining archives, and drafting and reviewing documents.
  8. 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.

Futran Tech Solutions Pvt. Ltd. is an equal opportunities employer and welcomes applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.



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