Manufacturing Validation Expert

  • Indianapolis, IN
  • Posted 6 days ago | Updated 3 days ago

Overview

On Site
Depends on Experience
Contract - W2
Contract - Independent
Contract - 12 Month(s)

Skills

Validation
MES
QMS
CAPA

Job Details

Job Title: Manufacturing Validation Expert
Work Location : Indianapolis, IN (onsite)
Contract duration: 12+ months Contract
Please note that 1st round will be F2F.
Need Local
Job Description

Mandatory skills*

Well versed with Manufacturing, Quality and engineering system and their validations.

OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), PAS/DCS Integrated with Manufacturing Equipment qualification

Domain- CSV Life Science

Candidate will provide an application validation expertise practically on different

scenarios as applicable case to case i.e., standalone/enterprise etc.

Candidate will be accountable for authoring Validation Plan, and Validation

Summary Reports and have fair understanding on other SDLC documents.

Candidate must have fair conceptual understanding on below key areas.

    • IT QMS
    • Validation/Qualification
    • Risk management.
    • Handling of defects/Deviations
    • Investigations
    • CAPA Handling
    • Test Management & Compliance

Candidate must have understating on latest regulations i.e., 21CFR Part 11, EU annex

11, and Guidelines e.g., GAMP5 guide.

OT System Qualification (Radio ligand Therapy or critical dosage forms will be

a plus)

PAS/DCS Qualification

ISA95 High level of understanding

OT Security will be a plus.

Standalone Systems Qualifications

PAS/DCS Integrated with Manufacturing Equipment qualification.

Essentials / Desirable

10 to 12 years of Professional experience and strong knowledge with real time

experience in IT Quality & Compliance, Computer System Validation / Software

Testing / System Implementation in the Life Sciences industry.

Well versed with Manufacturing, Quality and engineering system and their

validations.

Stakeholder management and good executor with required communication.

Knowledge of Pharmaceutical / Life Sciences as domain.

Experience to MES, QMS (Track wise), Lab solutions i.e., LIMS, Empower CDS,

Chrome Leon, Business Analytics, Middle wares etc..

Nice to Have Skills

Hands-on experience on testing tools like HP ALM, Kneat and SNOW

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