Validation Engineer

Indianapolis, IN - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Responsibilities:

Provide application/system validation expertise for standalone enterprise and integrated systems in a regulated (GxP) environment.
Lead OT system qualification and validation including Client/DCS integrated with manufacturing equipment.
Support qualification activities in Radio Ligand Therapy (RLT) or critical dosage forms (preferred).
Author and review Validation Plans Test Scripts/Protocols and Validation Summary Reports.
Ensure alignment with SDLC deliverables and IT Quality Management Systems (IT QMS).
Conduct and manage risk assessments deviations investigations CAPA handling test management and compliance activities.
Ensure compliance with 21 CFR Part 11 EU Annex 11 GAMP5 guidelines and other regulatory requirements.
Validate Standalone Systems and support ISA95-based manufacturing integration.
Collaborate with Manufacturing Quality and Engineering teams to ensure successful validation and compliance.
Consider OT Security requirements during qualification and validation projects.
Contribute to Agile/DevOps-based validation approaches.

Requirements:

8 9 years of relevant experience in CSV/IT Quality & Compliance within the Life Sciences industry.
Expertise in OT system qualification/validation especially:
Client/DCS systems integrated with manufacturing equipment.
Radio Ligand Therapy (RLT) or critical dosage forms (preferred).
Strong knowledge of Manufacturing Quality and Engineering system validations.
Experience with risk management deviation/defect handling investigations CAPA handling test management & compliance.
Hands-on experience authoring validation documentation (VP IQ OQ PQ VSR).
Deep understanding of 21 CFR Part 11 EU Annex 11 GAMP5 guidelines.
Familiarity with Standalone and Enterprise system qualifications.
Knowledge of ISA95 architecture for manufacturing operations.
OT system qualification in Radio Ligand Therapy or critical dosage forms.
Client/DCS qualification with integration experience.
Knowledge of MES QMS (Track Wise) LIMS Empower CDS Chrome Leon Business Analytics Middleware systems.
Experience with OT Security requirements in regulated environments.

Nice to Have Skills:

Hands-on experience with testing/validation tools such as:
Client ALM.
Kneat.
ServiceNow (SNOW).

Responsibilities: Provide application/system validation expertise for standalone enterprise and integrated systems in a regulated (GxP) environment. Lead OT system qualification and validation including Client/DCS integrated with manufacturing equipment. Support qualification activities in Radio Li...

Responsibilities:

Provide application/system validation expertise for standalone enterprise and integrated systems in a regulated (GxP) environment.
Lead OT system qualification and validation including Client/DCS integrated with manufacturing equipment.
Support qualification activities in Radio Ligand Therapy (RLT) or critical dosage forms (preferred).
Author and review Validation Plans Test Scripts/Protocols and Validation Summary Reports.
Ensure alignment with SDLC deliverables and IT Quality Management Systems (IT QMS).
Conduct and manage risk assessments deviations investigations CAPA handling test management and compliance activities.
Ensure compliance with 21 CFR Part 11 EU Annex 11 GAMP5 guidelines and other regulatory requirements.
Validate Standalone Systems and support ISA95-based manufacturing integration.
Collaborate with Manufacturing Quality and Engineering teams to ensure successful validation and compliance.
Consider OT Security requirements during qualification and validation projects.
Contribute to Agile/DevOps-based validation approaches.

Requirements:

8 9 years of relevant experience in CSV/IT Quality & Compliance within the Life Sciences industry.
Expertise in OT system qualification/validation especially:
Client/DCS systems integrated with manufacturing equipment.
Radio Ligand Therapy (RLT) or critical dosage forms (preferred).
Strong knowledge of Manufacturing Quality and Engineering system validations.
Experience with risk management deviation/defect handling investigations CAPA handling test management & compliance.
Hands-on experience authoring validation documentation (VP IQ OQ PQ VSR).
Deep understanding of 21 CFR Part 11 EU Annex 11 GAMP5 guidelines.
Familiarity with Standalone and Enterprise system qualifications.
Knowledge of ISA95 architecture for manufacturing operations.
OT system qualification in Radio Ligand Therapy or critical dosage forms.
Client/DCS qualification with integration experience.
Knowledge of MES QMS (Track Wise) LIMS Empower CDS Chrome Leon Business Analytics Middleware systems.
Experience with OT Security requirements in regulated environments.