Katalyst CRO
Validation Expert for Manufacturing Equipment Qualification
Katalyst CRO - Indianapolis, Indiana, us, 46262
Work at Katalyst CRO
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Overview
Validation Expert for Manufacturing Equipment Qualification
Join to apply for the
Validation Expert for Manufacturing Equipment Qualification
role at
Katalyst CRO Validation Expert for Manufacturing Equipment Qualification
7 months ago Be among the first 25 applicants Join to apply for the
Validation Expert for Manufacturing Equipment Qualification
role at
Katalyst CRO The candidate is expected to demonstrate excellent core competence and experience in delivery of IT CSV projects following 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 of the key areas below. IT QMS. Validation/Qualification. Handling of defects/Deviations. Investigations. Test Management & Compliance. Candidate must have an understanding of the 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). Client/DCS Qualification. ISA95 High level of understanding. OT Security will be a plus. Standalone Systems Qualifications. Client/DCS Integrated with Manufacturing Equipment qualification.
Responsibilities
The candidate is expected to demonstrate excellent core competence and experience in delivery of IT CSV projects following 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 of the key areas below. IT QMS. Validation/Qualification. Risk management. Handling of defects/Deviations. Investigations. CAPA Handling. Test Management & Compliance. Candidate must have an understanding of the 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). Client/DCS Qualification. ISA95 High level of understanding. OT Security will be a plus. Standalone Systems Qualifications. Client/DCS Integrated with Manufacturing Equipment qualification.
Requirements
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 in MES, QMS (Track wise), Lab solutions i.e., LIMS, Empower CDS, Chrome Leon, Business Analytics, Middle wares etc. Hands-on experience on testing tools like Client ALM, Kneat and SNOW. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Validation Specialist jobs in
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Join to apply for the
Validation Expert for Manufacturing Equipment Qualification
role at
Katalyst CRO Validation Expert for Manufacturing Equipment Qualification
7 months ago Be among the first 25 applicants Join to apply for the
Validation Expert for Manufacturing Equipment Qualification
role at
Katalyst CRO The candidate is expected to demonstrate excellent core competence and experience in delivery of IT CSV projects following 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 of the key areas below. IT QMS. Validation/Qualification. Handling of defects/Deviations. Investigations. Test Management & Compliance. Candidate must have an understanding of the 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). Client/DCS Qualification. ISA95 High level of understanding. OT Security will be a plus. Standalone Systems Qualifications. Client/DCS Integrated with Manufacturing Equipment qualification.
Responsibilities
The candidate is expected to demonstrate excellent core competence and experience in delivery of IT CSV projects following 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 of the key areas below. IT QMS. Validation/Qualification. Risk management. Handling of defects/Deviations. Investigations. CAPA Handling. Test Management & Compliance. Candidate must have an understanding of the 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). Client/DCS Qualification. ISA95 High level of understanding. OT Security will be a plus. Standalone Systems Qualifications. Client/DCS Integrated with Manufacturing Equipment qualification.
Requirements
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 in MES, QMS (Track wise), Lab solutions i.e., LIMS, Empower CDS, Chrome Leon, Business Analytics, Middle wares etc. Hands-on experience on testing tools like Client ALM, Kneat and SNOW. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Validation Specialist jobs in
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Indianapolis, IN $67,500.00-$96,400.00 12 hours ago Indianapolis, IN $56,980.00-$67,005.00 5 days ago Computer Systems Quality Assurance (CSQA)
Computer Systems Quality Assurance (CSQA)
Quality Control/Quality Assurance Specialist
Indianapolis, IN $56,980.00-$85,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr