CSV Engineer

Hyde Engineering + Consulting, Inc.; Hyderabad; Presencial; INR 1.400.000 - 2.100.000; Jornada completa

Descripción de la vacante

Hyde Engineering + Consulting, Inc. in India is seeking an experienced Computer Systems Validation professional for pharma/biopharmaceutical manufacturing environments.

You will lead validation projects for FUE qualification and automation systems, including DeltaV, Emerson, Honeywell, and Rockwell PLC, coordinating contractors and junior staff. The role requires strong writing and communication skills, familiarity with FAT/SAT/IQ/OQ, and knowledge of GAMP5, ISPE, PDA guidelines.

Formación

• 5+ years of experience in Computer Systems Validation in pharma/biopharmaceutical manufacturing.
• Knowledge of FUE qualification and unit operations automation with Honeywell, DeltaV, and PLC-based systems Computerized systems validation
• Experience with change controls, investigations, deviations, and CAPAs
• Technical understanding and experience of automation platforms, such as DeltaV, Emerson, Honeywell, Rockwell PLC, Siemens XFP
• Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results
• Working closely with the systems integrators, automation leads & process leads
• Completing the FAT, SAT's, IQ, OQ. creating and executing the protocols & documentation
• Knowledge of E2500,V Model concepts along with GAMP5, S88,S95
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments
• Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills
• Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus
• Ability to travel up to 50% or more within and outside India
• Knowledge of Delta-V DCS systems, Rockwell qualification
• Knowledge of PI Historian.
• Large scale project experience.
• Valid Passport with no restrictions to travel any geography

Responsabilidades

• 5+ years of experience in a Computer Systems Validation role in a Pharma, biopharmaceutical manufacturing environment.
• Facilities, Utilities, and Equipment (FUE) qualification Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems Computerized systems validation
• Support to change controls, investigations, deviations, and CAPAs
• Technical understanding and experience of automation platforms, such as DeltaV, Emerson, Honeywell, Rockwell PLC, Siemens XFP
• Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results
• Working closely with the systems integrators, automation leads & process leads
• Completing the FAT, SAT's, IQ, OQ. creating and executing the protocols & documentation
• Knowledge of E2500,V Model concepts along with GAMP5, S88,S95
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments
• Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills
• Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus
• Ability to travel up to 50% or more within and outside India
• Knowledge of Delta-V DCS systems, Rockwell qualification
• Knowledge of PI Historian.
• Large scale project experience.
• Valid Passport with no restrictions to travel any geography

Conocimientos

CSV expertise

Automation platforms

Project leadership

Communication skills

Travel flexibility

Educación

Engineering degree in Chemical, Automation, Biotechnology

Herramientas

DeltaV DCS

Rockwell PLC

Siemens XFP

Emerson

Honeywell

PI Historian

MS Office

MS Project

Visio

Descripción del empleo

#LI-HM1

• 5+ years of experience in a Computer Systems Validation role in a Pharma, biopharmaceutical manufacturing environment.
• Facilities, Utilities, and Equipment (FUE) qualification Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems Computerized systems validation
• Support to change controls, investigations, deviations, and CAPAs
• Technical understanding and experience of automation platforms, such as DeltaV, Emerson, Honeywell, Rockwell PLC, Siemens XFP
• Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results
• Working closely with the systems integrators, automation leads & process leads
• Completing the FAT, SAT's, IQ, OQ. creating and executing the protocols & documentation
• Knowledge of E2500,V Model concepts along with GAMP5, S88,S95
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments
• Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills
• Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus
• Ability to travel up to 50% or more within and outside India
• Knowledge of Delta-V DCS systems, Rockwell qualification
• Knowledge of PI Historian.
• Valid Passport with no restrictions to travel any geography

Responsibilities

• 5+ years of experience in a Computer Systems Validation role in a Pharma, biopharmaceutical manufacturing environment.
• Facilities, Utilities, and Equipment (FUE) qualification Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems Computerized systems validation
• Support to change controls, investigations, deviations, and CAPAs
• Technical understanding and experience of automation platforms, such as DeltaV, Emerson, Honeywell, Rockwell PLC, Siemens XFP
• Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results
• Working closely with the systems integrators, automation leads & process leads
• Completing the FAT, SAT's, IQ, OQ. creating and executing the protocols & documentation
• Knowledge of E2500,V Model concepts along with GAMP5, S88,S95
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments
• Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills
• Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus
• Ability to travel up to 50% or more within and outside India
• Knowledge of Delta-V DCS systems, Rockwell qualification
• Knowledge of PI Historian.
• Large scale project experience.
• Valid Passport with no restrictions to travel any geography

Education

• Engineering degree in Chemical, Automation, Biotechnology.