Validation (CSV) Project Manager
4 weeks ago
- Project Planning: Develop comprehensive project plans for validation activities, outlining scope, timelines, resources, and deliverables. Collaborate with cross-functional teams to ensure alignment with project goals.
- GMP Compliance: Ensure all validation processes adhere to GMP guidelines and other relevant regulatory standards. Stay updated on changes in regulatory requirements and communicate them to the project team.
- Equipment and Process Validation: Oversee the validation of manufacturing equipment and processes to ensure compliance with GMP and quality standards. Develop and execute validation protocols and reports.
- Qualification and Validation Documentation: Manage the creation, review, and approval of qualification and validation documentation, including validation plans, protocols, and summary reports.
- Change Control: Implement and manage change control processes related to validated systems and processes. Ensure that changes are assessed, documented, and validated as required.
- Risk Management: Identify and manage risks associated with validation projects, implementing mitigation strategies as necessary.
- Mandatory - 21CFR, GMP, CSV
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Senior Validation Project Manager
3 weeks ago
San Mateo, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. ...
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CSV Specialist
2 months ago
San Lorenzo, United States QRC Group Full timeSan Lorenzo, Puerto Rico | Posted on 03/25/2024 CSV Specialist for validation of laboratory instruments with LIMS connection (HPLC, Gas Chromatographer, Instron pull testers) Requirements Bachelor Degree in Science At least 5 years of experience in related area #J-18808-Ljbffr
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Senior Validation Engineer
1 month ago
San Francisco, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Write technical documents associated with projects. Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV) for facility and utility systems. Perform (hands on) field execution of commissioning and/or validation documentation. Reviewing equipment lists, instrument lists, drawings, specifications, and submittals...
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Validation Engineer
2 months ago
San Diego, United States ECQR Inc Full timeE-CQR is a San Diego based company and offers a broad range of business solutions and technology services to help clients in achieving their business goals. Our top notch consultants are providing services to industry's top Pharmaceutical Biotechnology Medical device Clinical research Diagnostics Chemical Bio Medical Drug development ...
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Validation Engineer
1 week ago
San Diego, United States ECQR Inc Full timeE-CQR is a San Diego based company and offers a broad range of business solutions and technology services to help clients in achieving their business goals. Our top notch consultants are providing services to industry's top Pharmaceutical Biotechnology Medical device Clinical research Diagnostics Chemical Bio Medical Drug development ...
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Sr. CSV-GxP
5 days ago
San Francisco, United States LS Solutions Full timeJob DescriptionJob DescriptionPosition: Sr. CSV-GxPDuration: 6 monthsLocation: San Francisco, CA 94158Job Description:Consultant shall provide Computer System Validation services to support the validation of GxP Computerized systems. This includes, but is not limited to, the generation of following end to end life-cycle validation deliverables - Business...
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Validation Engineer
2 months ago
San Diego, California, United States ECQR Inc Full timeE-CQR is a San Diego based company and offers a broad range of business solutions and technology services to help clients in achieving their business goals. Our top notch consultants are providing services to industry's top Pharmaceutical Biotechnology Medical device Clinical research Diagnostics Chemical Bio Medical Drug development Bioinformatics and...
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Computer Systems Validation Engineer III
3 weeks ago
San Diego, United States Ajinomoto Bio-Pharma Services Full timeWhy join Ajinomoto Bio-Pharma? Our mission is to help improve the health of humankind. We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique...
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Computer Systems Validation Engineer III
1 week ago
San Diego, United States Ajinomoto Bio-Pharma Services Full timeWhy join Ajinomoto Bio-Pharma? Our mission is to help improve the health of humankind. We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique...
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Project Manager
4 weeks ago
San Mateo, United States eTeam Full timeSeasoned PM, GxP Validation Exp, SAP Implementation Exp, PMP, Seasoned Senior PM with strong experience Life Science Domain Project Management skills GxP experience with Validation knowledge is a must Organize validation related activities and deliverables in accordance with the project timelines. Make sure individual validation activities are...
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SAP Validation Lead
4 weeks ago
San Francisco, United States Tekfortune Inc Full timeTitle: SAP Validation Lead - ERP Location: King Of Prussia, PA JOB Description: Roles and Responsibilities 2-4 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with...
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SAP Validation Lead
1 week ago
San Francisco, United States Tekfortune Inc Full timeTitle: SAP Validation Lead - ERP Location: King Of Prussia, PA JOB Description: Roles and Responsibilities 2-4 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with...
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Validation Engineer
2 weeks ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob Description Job Description Santa Monica, CA Contract Duration: 6-18 months Rate: Negotiable Responsibilities: Excellent employment opportunity for a Validation Engineer III in the Santa Monica, CA area. Responsible for performing the validation of computer systems. This includes developing validation master plans with minimum supervision, preparing...
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Validation Engineer
1 month ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob DescriptionJob DescriptionSanta Monica, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Validation Engineer III in the Santa Monica, CA area.Responsible for performing the validation of computer systems. This includes developing validation master plans with minimum supervision, preparing protocols...
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Validation Engineer
1 week ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob DescriptionJob DescriptionSanta Monica, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Validation Engineer III in the Santa Monica, CA area.Responsible for performing the validation of computer systems. This includes developing validation master plans with minimum supervision, preparing protocols...
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SAP Validation Lead
2 weeks ago
San Francisco, CA, United States Tekfortune Inc Full timeTitle: SAP Validation Lead - ERP Location: King Of Prussia, PA JOB Description: Roles and Responsibilities 2-4 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure...
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Validation Engineer
4 weeks ago
San Antonio, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Write qualification and validation protocols/reports and other documentation related to the activities Responsible for performing process and equipment validation activities including, but not limited to, gathering historical data for product manufacture, analyzing data using statistical principles, writing validation protocols and...
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Project Engineer
2 weeks ago
San Diego, United States Project Farma Full timeProject Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy and execution to start up and established gene and cell therapy, pharmaceutical, and biotechnology companies. We are an industry leader in providing project management, validation, engineering,...
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Project Engineer
1 week ago
San Diego, United States Project Farma Full timeProject Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy and execution to start up and established gene and cell therapy, pharmaceutical, and biotechnology companies. We are an industry leader in providing project management, validation, engineering,...
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Project Engineer
1 week ago
San Diego, United States Project Farma Full timeProject Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy and execution to start up and established gene and cell therapy, pharmaceutical, and biotechnology companies. We are an industry leader in providing project management, validation, engineering,...