CQV Engineer

2 weeks ago

Hyderabad, India Tek Support Full time
Key Responsibilities:Lead Quality Investigations:

Conduct thorough quality investigations within sterile/aseptic manufacturing environments, identifying root causes and implementing corrective actions.Execute CQV Activities:

Oversee and execute

Commissioning, Qualification, and Validation (CQV)

activities for equipment, systems, and processes in sterile/aseptic facilities.Thermal Mapping:

Perform and manage thermal mapping to ensure compliance with regulatory and industry standards for temperature control and monitoring.Sterilization/SIP Processes:

Support and enhance

Sterilization/SIP

processes, ensuring all procedures meet the required standards for aseptic environments.Regulatory Compliance:

Ensure all CQV activities comply with regulatory requirements, including

GMP ,

FDA , and other relevant industry standards.Cross-Functional Collaboration:

Work closely with cross-functional teams, including Quality Assurance, Operations, and Engineering, to resolve quality issues and drive continuous improvement initiatives.Documentation and Reporting:

Prepare detailed reports and documentation related to CQV activities, including validation protocols, test results, and corrective actions, ensuring adherence to Good Documentation Practices (GDP).Risk Assessment:

Conduct risk assessments and identify potential areas of improvement to optimize processes and enhance product quality.

Client Requirements:Experience:

Minimum 8+ years of experience in quality investigations, specifically within sterile/aseptic environments.CQV Expertise:

Demonstrated experience in

Commissioning, Qualification, and Validation (CQV) , with a particular focus on sterile/aseptic facilities.Thermal Mapping:

Proven expertise in performing and overseeing

thermal mapping

processes is essential.Sterilization/SIP:

Experience in

Sterilization/SIP

processes is highly desirable.Regulatory Knowledge:

In-depth understanding of industry standards and regulations, including

GMP ,

FDA , and other regulatory guidelines for sterile manufacturing environments.Problem-Solving Skills:

Strong analytical and problem-solving abilities, with a focus on resolving complex quality issues.Collaboration:

Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.

Qualifications:Bachelor's degree

in Engineering, Life Sciences, or a related field.Proven track record of success in

CQV

roles within sterile/aseptic manufacturing environments.Strong knowledge of

thermal mapping ,

sterilization/SIP , and quality investigation processes.Familiarity with regulatory standards such as

GMP ,

FDA , and other relevant guidelines.

  • CQV Engineer

    2 weeks ago

    Hyderabad, India Tek Support Full time

    Key Responsibilities:Lead Quality Investigations: Conduct thorough quality investigations within sterile/aseptic manufacturing environments, identifying root causes and implementing corrective actions.Execute CQV Activities: Oversee and execute Commissioning, Qualification, and Validation (CQV) activities for equipment, systems, and processes in...

  • Senior CSV

    2 weeks ago

    Hyderabad, India Tek Support Full time

    Job Summary:We are seeking a highly experiencedSenior CSV Engineer/Analystto oversee lab system configuration, system integration, and ensure compliance withcGMPand regulatory standards. This role is critical to managing the validation of laboratory and manufacturing systems, ensuring system reliability and regulatory compliance. The ideal candidate will...

  • Senior CSV

    2 weeks ago

    Hyderabad, India Tek Support Full time

    Job Summary:We are seeking a highly experienced Senior CSV Engineer/Analyst to oversee lab system configuration, system integration, and ensure compliance with cGMP and regulatory standards. This role is critical to managing the validation of laboratory and manufacturing systems, ensuring system reliability and regulatory compliance. The ideal candidate will...

  • Senior Process Engineer

    4 months ago

    hyderabad, India Hyde Engineering + Consulting Full time

    Key Responsibilities: Assist the Lead Process Engineer with conceptual design deliverables such as Process Flow Diagrams, Material and Energy Balances. Design utilities generation and distribution systems for new and existing manufacturing processes, including Utility Sizing models. Generate Process P&IDs that include, process...

  • Senior Process Engineer

    5 days ago

    hyderabad, India Hyde Engineering + Consulting Full time

    Key Responsibilities: Assist the Lead Process Engineer with conceptual design deliverables such as Process Flow Diagrams, Material and Energy Balances. Design utilities generation and distribution systems for new and existing manufacturing processes, including Utility Sizing models. Generate Process P&IDs that include, process...

  • Senior Process Engineer

    4 months ago

    Hyderabad, India Hyde Engineering + Consulting Full time

    Key Responsibilities: Assist the Lead Process Engineer with conceptual design deliverables such as Process Flow Diagrams, Material and Energy Balances. Design utilities generation and distribution systems for new and existing manufacturing processes, including Utility Sizing models. Generate Process P&IDs that include, process...

  • Lead/Senior HVAC Design Engineer

    5 days ago

    hyderabad, India Hyde Engineering + Consulting Full time

    Assist the Lead Process Engineer with conceptual design deliverables such as Process Flow Diagrams, Material and Energy Balances.  Acts as a drug product technical expert to provide solutions when troubleshooting issues in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection, and transportation, for...

  • AutoCAD Draftsperson- 2D and/or 3D

    4 months ago

    hyderabad, India Hyde Engineering + Consulting Full time

    Assist the Lead Process Engineer with conceptual design deliverables such as Process Flow Diagrams, Material and Energy Balances.  Acts as a drug product technical expert to provide solutions when troubleshooting issues in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection, and transportation, for...

  • AutoCAD Draftsperson- 2D and/or 3D

    4 months ago

    Hyderabad, India Hyde Engineering + Consulting Full time

    Assist the Lead Process Engineer with conceptual design deliverables such as Process Flow Diagrams, Material and Energy Balances.  Acts as a drug product technical expert to provide solutions when troubleshooting issues in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection, and transportation, for...