CSV Validation Engineer
3 weeks ago
Job Description:Responsibilities:Must Have:10 + years Experience in Validating GxP applications.Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy.Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality.Support Risk assessment.Document Regulatory Requirements and Review Specification documentation (viz. User Stories, URS, FRS).Review and final Approval of requirements, Technical Design and Solution Architecture Plan, IQ, OQ and PQ pre and post execution documents.Lead, Write, Review/ Approve Discrepancy Logs (final dispositions).Lead, Write, Review / Approve Requirement Traceability Matrix (RTM) and Validation Summary Reports.Good To Have:Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification.Conduct Periodic Reviews of GxP Apps as per the frequency stated in the governing SOP and write Periodic review reports and Review and Approve Periodic.Review Reports:Tracks the Periodic review findings and open CAPA s to a closure.Review and Approve System Support and Operations plan.Participate in and support Audits.Contribute and Review/ Approve Decommissioning Plans & Decommissioning Reports.Contribute, Review/ Approve deliverables for Change Management Support.Maintain validation documentation throughout product lifecycle a result of Change, Periodic Review, Audits.Communication.Immaculate communication and handles multiple clients/ projects.Works in Consulting capacity.To ensure process improvement and compliance, and participate in technical design discussion and to review technical documents.Coordination with On-Site Engineers and attending customer calls.Raising risks, issues and escalation to senior management and customers.To create all quality documents, collect metrics data and conduct Audits.To perform Value creation and KM activities.To create project plans and keep track of schedule for on time delivery as per the defined quality standards.#J-18808-Ljbffr
by Jobble
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Validation Engineer
3 weeks ago
Raleigh, United States Hugheseng Full timeDescription Hughes Engineering & Consulting is an exciting, fast-growing company focused on Process Engineering, Project Engineering, Project Management and CQV solutions for the pharmaceutical industry. We offer great benefits, and exciting challenges for both career development as well as personal leadership development. Company Culture Guidelines &...
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Validation Engineer
2 weeks ago
Raleigh, United States Hughes Engineering, PLLC Full timeHughes Engineering & Consulting is an exciting, fast-growing company focused on Process Engineering, Project Engineering, Project Management and CQV solutions for the pharmaceutical industry. We offer great benefits, and exciting challenges for both career development as well as personal leadership development. Company Culture Guidelines & Values: We are...
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Process Validation Engineer
3 days ago
Raleigh, United States Piper Companies Full timePiper Life Sciences is actively seeking a Process Validation Engineer to join a global pharmaceuticalcompany that addresses unmet medical needs of people living with and chronic and ongoing disorders. This position will work traditional hours, Monday - Friday, in the greater Raleigh, North Carolina area. Responsibilities for the Process Validation Engineer:...
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Cleaning Validation Engineer
2 days ago
Raleigh, United States Mastech Digital Full timeRole: Cleaning Validation Engineer Raleigh, NC Contract role. Do you have the skills to fill this role Read the complete details below, and make your application today. Job Description: Looking for a Cleaning Validation Engineer. Heavy background in Cleaning Validation in the biotech and pharma. No med device please. Should be confident working along but...
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Biopharmaceutical VALIDATION ENGINEER/SPECIALIST
2 weeks ago
Raleigh, United States MMR Consulting Inc Full timePrevious Pharmaceutical/Biotech experience is mandatory for this role. MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering....
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CSV Technical Lead
2 weeks ago
Raleigh, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: 10 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality Support Risk...
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CSV Consultant
2 weeks ago
Raleigh, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: We are looking for a pure validation resource with periodic review, audit experience. 10 + years' Experience in Validating GxP applications Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy. Provides consultation and counseling on...
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Validation Lead
4 weeks ago
Raleigh, United States EPM Scientific Full timeValidation LeadLocation: Raleigh, NCWorking Situation: OnsiteA global speciality pharmaceutical company is looking to bring on a Validation Lead to support the global quality organization. You will be supporting tech transfer and validation activities while also working cross-functionally to support all GxP related issues at the Raleigh, NC site.The...
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Validation Lead
4 weeks ago
Raleigh, United States EPM Scientific Full timeValidation LeadLocation: Raleigh, NCWorking Situation: OnsiteA global speciality pharmaceutical company is looking to bring on a Validation Lead to support the global quality organization. You will be supporting tech transfer and validation activities while also working cross-functionally to support all GxP related issues at the Raleigh, NC site.The...
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Validation Lead
4 weeks ago
Raleigh, United States EPM Scientific Full timeValidation LeadLocation: Raleigh, NCWorking Situation: OnsiteA global speciality pharmaceutical company is looking to bring on a Validation Lead to support the global quality organization. You will be supporting tech transfer and validation activities while also working cross-functionally to support all GxP related issues at the Raleigh, NC site.The...
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Validation Lead
1 week ago
Raleigh, United States LAPORTE Full timeThis position is responsible for supporting the validation and quality engineering of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas and assure the equipment/system and validation programs are compliant with client's global/site standards and industry practices.Responsibilities and Duties: Located in...
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Validation Lead
4 weeks ago
Raleigh, United States LAPORTE Full timeThis position is responsible for supporting the validation and quality engineering of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas and assure the equipment/system and validation programs are compliant with client’s global/site standards and industry practices.Responsibilities and Duties: Located in...
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Validation Lead
4 weeks ago
Raleigh, United States LAPORTE Full timeThis position is responsible for supporting the validation and quality engineering of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas and assure the equipment/system and validation programs are compliant with client’s global/site standards and industry practices.Responsibilities and Duties: Located in...
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Validation Lead
4 weeks ago
Raleigh, United States LAPORTE Full timeThis position is responsible for supporting the validation and quality engineering of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas and assure the equipment/system and validation programs are compliant with client’s global/site standards and industry practices.Responsibilities and Duties: Located in...
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Quality Validation Manager
3 weeks ago
Raleigh, United States SciPro Full timeQuality Validation Manager – On-SiteThis is an opportunity to work on a brand-new Manufacturing site for one of the most innovative and impactful Pharmaceutical manufacturers in the state of North Carolina. With a vast pipeline that is ever growing, we are looking for an experienced and independent expert in Quality & Validation tasks to join the team on a...
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Quality Validation Manager
3 weeks ago
Raleigh, United States SciPro Full timeQuality Validation Manager – On-SiteThis is an opportunity to work on a brand-new Manufacturing site for one of the most innovative and impactful Pharmaceutical manufacturers in the state of North Carolina. With a vast pipeline that is ever growing, we are looking for an experienced and independent expert in Quality & Validation tasks to join the team on a...
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Quality Validation Manager
4 weeks ago
Raleigh, United States SciPro Full timeQuality Validation Manager – On-SiteThis is an opportunity to work on a brand-new Manufacturing site for one of the most innovative and impactful Pharmaceutical manufacturers in the state of North Carolina. With a vast pipeline that is ever growing, we are looking for an experienced and independent expert in Quality & Validation tasks to join the team on a...
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Senior Biotech IT Infrastructure Lead
3 weeks ago
Raleigh, United States HireMinds Full timeSenior Biotech IT Infrastructure LeadLocation: North CarolinaHireMinds is helping build a client’s North Carolina manufacturing site. Are you ready to lead cutting-edge IT initiatives for this team? As the Senior Biotech IT Infrastructure Lead at US headquarters in Raleigh, NC, this pivotal role oversees the design, deployment, and leadership of...
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Senior Biotech IT Infrastructure Lead
3 weeks ago
Raleigh, United States HireMinds Full timeSenior Biotech IT Infrastructure LeadLocation: North CarolinaHireMinds is helping build a client’s North Carolina manufacturing site. Are you ready to lead cutting-edge IT initiatives for this team? As the Senior Biotech IT Infrastructure Lead at US headquarters in Raleigh, NC, this pivotal role oversees the design, deployment, and leadership of...
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Senior Biotech IT Infrastructure Lead
3 weeks ago
Raleigh, United States HireMinds Full timeSenior Biotech IT Infrastructure LeadLocation: North CarolinaHireMinds is helping build a client’s North Carolina manufacturing site. Are you ready to lead cutting-edge IT initiatives for this team? As the Senior Biotech IT Infrastructure Lead at US headquarters in Raleigh, NC, this pivotal role oversees the design, deployment, and leadership of...