Validation Engineer

3 weeks ago

Philadelphia, United States CareerBuilder Full time

Responsibilities:

Support all aspects of the Cleaning Validation Life Cycle for clients from development through qualification and monitoring .

Create/author/execute at a minimum , Validation Plans, V-cycle documents, Validation Summary Report, Qualification protocols/reports, and Performance Qualification protocols/reports.

Responsible for the qualification of cleaning manufacturing equipment independently in aseptic filling and GMP areas, including autoclave, Vessel Equipment validation, Sterilization in Place of filling vessels and COP validation in accordance with corporate and departmental procedures.

Participate i n cross-functional project team , including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient.

Experience with writing and executing Hold Time studies.

Experience with gowning in aseptic classified areas.

Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, and standard operating procedures.

Perform carry-over calculations and determine cleaning limits.

Must have demonstrated self-direct work habits and strong communication skills.

Must be a committed team player prepared to work in and embrace a team-based culture.

Familiarity with regulatory expectations regarding electronic records and electronic signatures.

Ability to work in a high complex matrix environment.

Sense of urgency, flexibility and accountability.

Ability to follow written procedures and document results in a neat and precise manner , following Good Documentation Practices .

Maintain attention to detail, while completing multiple or repetitive tasks.

Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.

Maintain a high level of integrity while balancing multiple priorities and responsibilities.

Requirements:

BS in science or engineering.

Minimum of 5 years pharmaceutical/biotech experience in validation with knowledge .

Proficient and experience with Kaye validators and temperature data loggers to independently perform temperature mapping studies for autoclave and Vessel SIP

Proficient and experience with sampling for cleaning validation including independently performing swabbing and taking rinse samples.

Prior experience preparing and executing equipment qualification documents required.

SME experience in the following areas is preferred :

Sterilization Validation (autoclave and vessel SIP)

#J-18808-Ljbffr

  • Validation Engineer

    5 days ago

    Philadelphia, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Support all aspects of the Cleaning Validation Life Cycle for clients from development through qualification and monitoring . Create/author/execute at a minimum , Validation Plans, V-cycle documents, Validation Summary Report, Qualification protocols/reports, and Performance Qualification protocols/reports. Responsible for the...

  • Process Validation Engineer

    2 weeks ago

    Philadelphia, United States a Biopharmaceutical company based out PA Full time

    Process Validation Engineer (Contract)RESPONSIBILITIESOverseeing and reviewing design and construction work related to process improvements in a cGMP manufacturing facility.Supporting startup, Commissioning, Qualification, and Validation (CQV) of process equipment, and developing process technical transfer documents.Collaborating with senior leadership to...

  • Process Validation Engineer

    5 days ago

    Philadelphia, United States a Biopharmaceutical company based out PA Full time

    Process Validation Engineer (Contract) RESPONSIBILITIES Overseeing and reviewing design and construction work related to process improvements in a cGMP manufacturing facility. Supporting startup, Commissioning, Qualification, and Validation (CQV) of process equipment, and developing process technical transfer documents. Collaborating with senior leadership...

  • Chief Engineering Director Verification

    14 hours ago

    New Philadelphia, United States Crane Carrier Company Full time

    Visa sponsorship is not supported for this position - Battle Motors prides itself on delivering efficient, effective solutions for the heavy-duty work truck industry. With the evolution of our new EV (Electric Vehicle) technology, we are growing fast Director, Verification, Validation, Chief, Production Engineer, Validation Engineer, Technology

  • Mechanical Engineer

    1 month ago

    Philadelphia, United States PROMAN Staffing USA Full time

    PROMAN Staffing has partnered with global pharma packaging solutions provider to source and hire a PACKAGING MECHANICAL ENGINEER to join their Engineering team department onsite at their Philadelphia, PA facility.This is a DIRECT HIRE opportunity!The Packaging Mechanical Engineer will support and collaborate with the client’s Manufacturing Operations team...

  • Mechanical Engineer

    1 month ago

    Philadelphia, United States PROMAN Staffing USA Full time

    PROMAN Staffing has partnered with global pharma packaging solutions provider to source and hire a PACKAGING MECHANICAL ENGINEER to join their Engineering team department onsite at their Philadelphia, PA facility.This is a DIRECT HIRE opportunity!The Packaging Mechanical Engineer will support and collaborate with the client’s Manufacturing Operations team...

  • Mechanical Engineer

    2 weeks ago

    Philadelphia, United States PROMAN Staffing USA Full time

    PROMAN Staffing has partnered with global pharma packaging solutions provider to source and hire a PACKAGING MECHANICAL ENGINEER to join their Engineering team department onsite at their Philadelphia, PA facility. This is a DIRECT HIRE opportunity! The Packaging Mechanical Engineer will support and collaborate with the clients Manufacturing Operations team...

  • Mechanical Engineer

    1 month ago

    Philadelphia, United States PROMAN Staffing USA Full time

    PROMAN Staffing has partnered with global pharma packaging solutions provider to source and hire a PACKAGING MECHANICAL ENGINEER to join their Engineering team department onsite at their Philadelphia, PA facility.This is a DIRECT HIRE opportunity!The Packaging Mechanical Engineer will support and collaborate with the client’s Manufacturing Operations team...

  • Mechanical Engineer

    2 weeks ago

    Philadelphia, United States PROMAN Staffing USA Full time

    PROMAN Staffing has partnered with global pharma packaging solutions provider to source and hire a PACKAGING MECHANICAL ENGINEER to join their Engineering team department onsite at their Philadelphia, PA facility. Ensure you read the information regarding this opportunity thoroughly before making an application. This is a DIRECT HIRE opportunity! The...

  • Machine Learning Engineer

    1 week ago

    Philadelphia, United States V-Soft Consulting Group Full time

    Hiring- Machine Learning Engineer- Philadelphia, PA-Hybrid-Pure W2 only (No Transfers)Job Title: Machine Learning EngineerLocation: Philadelphia, PA-Hybrid Responsibility Implements, refines, and validates machine learning algorithms for products and applications. - Designs and develops data pipelines consisting of data ingest, data validation, data...

  • Machine Learning Engineer

    2 weeks ago

    Philadelphia, United States V-Soft Consulting Group, Inc. Full time

    Hiring- Machine Learning Engineer- Philadelphia, PA-Hybrid-Pure W2 only (No Transfers)Job Title: Machine Learning EngineerLocation: Philadelphia, PA-Hybrid Responsibility• Implements, refines, and validates machine learning algorithms for products and applications. - Designs and develops data pipelines consisting of data ingest, data validation, data...

  • Machine Learning Engineer

    5 days ago

    Philadelphia, United States V-Soft Consulting Group Full time

    Hiring- Machine Learning Engineer- Philadelphia, PA-Hybrid-Pure W2 only (No Transfers) Job Title: Machine Learning Engineer Location: Philadelphia, PA-Hybrid Responsibility Implements, refines, and validates machine learning algorithms for products and applications. - Designs and develops data pipelines consisting of data ingest, data validation, data...

  • Machine Learning Engineer

    1 week ago

    Philadelphia, United States V-Soft Consulting Group, Inc. Full time

    Hiring- Machine Learning Engineer- Philadelphia, PA-Hybrid-Pure W2 only (No Transfers)Job Title: Machine Learning EngineerLocation: Philadelphia, PA-Hybrid Responsibility• Implements, refines, and validates machine learning algorithms for products and applications. - Designs and develops data pipelines consisting of data ingest, data validation, data...

  • Engineer 3, Software Development

    2 weeks ago

    Philadelphia, United States Comcast Cable Communications LLC Full time

    Engineer 3, Software Development & Engineering -- SDET Contribute to the team responsible for designing, developing, delivering and supporting products and services for internet, TV and voice; architect, develop, and test new and upcoming Wi-Fi features that will be deployed in the Comcast footprint using Wireless/WiFi protocols; design, troubleshoot, and...

  • Operation & Maintenance Engineering Support

    3 weeks ago

    Philadelphia, United States Expleo Full time

    Job DescriptionJob DescriptionEXPLEO GROUP USA is looking for an Operation & Maintenance Engineering Support to join a dynamic and expanding team in Philadelphia, Washington, New York City and Boston.Expleo is a trusted partner for end-to-end, integrated engineering, quality services and management consulting for digital transformation. We are a talent...

  • Operation & Maintenance Engineering Support

    4 weeks ago

    Philadelphia, United States Expleo Full time

    Job DescriptionJob DescriptionEXPLEO GROUP USA is looking for an Operation & Maintenance Engineering Support to join a dynamic and expanding team in Philadelphia, Washington, New York City and Boston.Expleo is a trusted partner for end-to-end, integrated engineering, quality services and management consulting for digital transformation. We are a talent...

  • HCG Process Engineer

    2 weeks ago

    Philadelphia, United States Horizon Controls Group Full time

    Job DescriptionAs a Process engineer, you will mechanically troubleshoot, support identification and implementation of process improvements, system design, capital project support, and investigation support. You will also ensure all documentation deliverables are generated and develop new processes and/or optimize existing ones. Responsibilities:Acts as the...

  • Senior Quality Engineer

    31 minutes ago

    Philadelphia, United States Planet Pharma Full time

    (This is a full time permanent position available for people located in the Philadelphia, PA area)OverviewThe Senior Quality Engineer, Quality Assurance Engineering will provide Quality oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility along with associated software...

  • HCG Process Engineer

    3 days ago

    Philadelphia, United States Horizon Controls Group Full time

    Job Description As a Process engineer, you will mechanically troubleshoot, support identification and implementation of process improvements, system design, capital project support, and investigation support. You will also ensure all documentation deliverables are generated and develop new processes and/or optimize existing ones. Responsibilities: Acts as...

  • HCG Process Engineer

    3 weeks ago

    Philadelphia, United States Horizon Controls Group Full time

    Job DescriptionJob DescriptionAs a Process engineer, you will mechanically troubleshoot, support identification and implementation of process improvements, system design, capital project support, and investigation support. You will also ensure all documentation deliverables are generated and develop new processes and/or optimize existing ones....