Validation Engineer

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 12 Month(s)

Skills

IT QMS
Validation
Risk management

Job Details

Job Title: Validation Engineer

Location: Indianapolis ,IN

Duration : 12 months

 

 

Refer below OT system Qualification and validation is Must

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.

 

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

 

 

 

 

Agile or DevOps methodology. The successful candidate shall possess:

 

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.

o IT QMS

o Validation/Qualification

o Risk management.

o Handling of defects/Deviations

o Investigations

o CAPA Handling

o 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, Chromeleon, Business Analytics, Middle wares etc..

 

Nice to Have Skills

 

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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.