Validation Engineer
2 months ago
We are seeking a highly skilled Validation Engineer - II to join our team at ATR International. As a key member of our organization, you will play a critical role in ensuring the quality and integrity of our biologics products.
Responsibilities:- Develop and Implement CPV Strategies: Apply established commercial biologics Continued Process Verification (CPV) program strategies and contribute to CPV program of one or multiple biologics products.
- Statistical Analysis and Data Management: Author, review, and approve CPV protocols, reports, and present CPV data as needed to Subject Matter Experts (SMEs). Support batch processing data collection and verification activities.
- Process Improvement: Identify and implement improvements for data collection and management to enable quick and reliable data analysis.
- Global Process Monitoring: Provide statistical expertise for all global commercial process monitoring in compliance with current ICH / Health Authority, QbD guidelines and SOPs.
- Investigation Support: Assist in resolution of investigations doing statistical analysis.
- Complex Problem-Solving: Work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Technical Expertise: Experience with optimization and statistical data analysis tools such as Minitab, JMP, Spotfire, and R. Basic programming in R and Python preferred.
- Excellent Communication Skills: Excellent technical writing skill, working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing preferred.
- Problem-Solving Skills: Excellent troubleshooting skills and ability to solve complex technical issues.
- Industry Knowledge: Understanding of guidelines required by FDA, EMA, and other regulatory bodies. Extensive knowledge of industry practices.
- Interpersonal Skills: Excellent verbal, written, and interpersonal communication skills required. Ability to effectively manage multiple projects/priorities.
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Validation Engineer
3 weeks ago
New York, New York, United States ATR International Full timeJob Title: Validation Engineer - IIJob Summary:We are seeking a highly skilled Validation Engineer - II to join our team at ATR International. As a key member of our team, you will be responsible for applying established commercial biologics Continued Process Verification (CPV) program strategies and contributing to the CPV program of one or multiple...
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Validation Engineer
2 months ago
New York, New York, United States ATR International Full timeAbout the Role:We are seeking a highly skilled Validation Engineer - II to join our team at ATR International. As a key member of our organization, you will play a critical role in ensuring the quality and integrity of our biologics products.Responsibilities:Develop and implement commercial biologics Continued Process Verification (CPV) program strategies...
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Validation Specialist
1 month ago
New York, New York, United States ATR International Full timeJob Title: Validation EngineerAbout the Role:We are seeking a skilled Validation Engineer to join our team at ATR International. As a key member of our team, you will be responsible for ensuring the quality and integrity of our biologics products.Responsibilities:Develop and implement commercial biologics Continued Process Verification (CPV) program...
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Senior Validation Specialist
4 weeks ago
New York, New York, United States Intellectt Inc Full timeJob Title: Validation Engineer - PharmaLocation:New YorkJob Type:ContractJob Description: Intellectt Inc is seeking a skilled Validation Engineer to ensure the integrity and compliance of pharmaceutical manufacturing processes and systems. The successful candidate will be responsible for validating equipment, processes, and software to meet regulatory...
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Quality Lead/Lead Validation Engineer
4 days ago
New York, New York, United States Verista Full timeAt Verista, we are seeking a Quality Lead/Lead Validation Engineer to join our team. This role will be responsible for supporting the QISM group at the Client, specifically focused on IT Infrastructure and the Clinical Operations areas.This position will work closely with the operational functions, DTE (IT), and other GxP QA groups to provide oversight of...
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Validation Specialist
2 weeks ago
New York, New York, United States ATR International Full timeJob Title: Validation EngineerWe are seeking a skilled professional to join our team at ATR International as a Validation Engineer. The ideal candidate will have a strong background in statistics, process monitoring, and advanced statistical data analysis.Key Responsibilities:Develop and implement commercial biologics Continued Process Verification (CPV)...
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Quality Lead/Lead Validation Engineer
1 week ago
New York, New York, United States Verista Full timeJob SummaryVerista is seeking a highly skilled Quality Lead/Lead Validation Engineer to join our team. In this role, you will be responsible for supporting the QISM group at the Client, specifically focused on IT Infrastructure and the Clinical Operations areas.This position will work closely with operational functions, DTE (IT), and other GxP QA groups to...
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Senior Validation Specialist
4 weeks ago
New York, New York, United States Intellectt Inc Full timeCleaning Validation Compliance ProjectWe are seeking a highly experienced Cleaning Validation Engineer to join our team at Intellectt Inc.Key Responsibilities:Lead a 6+ month cleaning validation compliance project with our client.Collaborate with Subject Matter Experts (SMEs) with 7+ years of experience in cleaning validation and process development.Develop...
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Clinical Data Validator
2 weeks ago
New York, New York, United States NYC Health Hospitals Full timeJob Title: Clinical Data ValidatorNYC Health + Hospitals/Jacobi is a leading healthcare institution with a strong commitment to delivering high-quality care services. Our team is dedicated to ensuring the accuracy and integrity of patient data, and we are seeking a skilled Clinical Data Validator to join our team.Job SummaryThe Clinical Data Validator will...
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New York, New York, United States Cognizant North America Full timeJob Title: Validation/QA Supporting Data ScientistAs a Validation/QA Supporting Data Scientist, you will play a crucial role in ensuring the quality and accuracy of machine learning models. You will work closely with data scientists to document the model qualification plan and technical specification documents.Key Responsibilities:Document business and...
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Validation Specialist
1 month ago
New Brunswick, New Jersey, United States On Target Staffing Full timeValidation EngineerWe're seeking a skilled Validation Engineer to contribute to the success of our dynamic dietary supplement and OTC manufacturing company. As a key member of our team, you'll play a crucial role in validating our manufacturing systems and processes to ensure they meet quality, safety, and regulatory standards.Key Responsibilities:Develop...
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Validation Project Engineer
2 weeks ago
New Brunswick, New Jersey, United States PSC Biotech Full timeAbout the RolePSC Biotech is seeking an experienced and motivated Validation Project Engineer to plan, execute, and manage CQV projects, manage vendors, and provide technical review. This role will drive successful project and deliverable completion, adhering to industry standards and regulations.Key ResponsibilitiesDrive project success by assessing...
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Assistant Engineer
3 weeks ago
New York, New York, United States Hornblower Inc Full timeAbout the OpportunityThe Assistant Engineer is a key member of our Engineering Department, responsible for the maintenance and operation of mechanical and hydraulic equipment onboard our vessel, Seaward Endeavor.ResponsibilitiesInspect, maintain, and repair mechanical and hydraulic equipment, as well as lubricate moving parts of the engine and other...
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Assistant Engineer
1 month ago
New York, New York, United States Hornblower Inc Full timeAbout the OpportunityThe Assistant Engineer is a key member of our Engineering Department, responsible for the maintenance and operation of mechanical and hydraulic equipment onboard our vessel, Seaward Endeavor.ResponsibilitiesInspect, maintain, and repair mechanical and hydraulic equipment, as well as lubricate moving parts of the engine and other...
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Mechanical Engineer
1 month ago
New York, New York, United States Hornblower Inc Full timeAbout the OpportunityThe Assistant Engineer is a key member of our Engineering Department, responsible for the maintenance and operation of mechanical and hydraulic equipment onboard our vessel, Seaward Endeavor. This role requires a high level of adaptability, dynamism, and a strong commitment to our RESPECT Service System.Key ResponsibilitiesAssist in...
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Assistant Engineer
1 month ago
New York, New York, United States Hornblower Cruises and Events Full timeAbout the OpportunityThe Assistant Engineer is a key member of our Engineering Department, responsible for the maintenance and operation of mechanical and hydraulic equipment onboard our vessel, Seaward Endeavor. This role requires a high level of adaptability, dynamism, and a commitment to our RESPECT Service System.Key ResponsibilitiesInspect, maintain,...
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Mechanical Engineer Assistant
3 days ago
New York, New York, United States Hornblower Inc Full timeAbout the Opportunity:The Assistant Engineer is a key member of the Engineering Department responsible for the maintenance and operation of mechanical and hydraulic equipment onboard the vessel Seaward Endeavor.Key responsibilities include inspecting, maintaining, and repairing mechanical and hydraulic equipment, as well as lubricating moving parts of the...
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CQV Engineer
4 weeks ago
New York, New York, United States Mastech Digital Full timeCQV Engineer Job DescriptionWe are seeking an experienced CQV Engineer to join our team in Pennington, NJ. The ideal candidate will have a strong pharmaceutical background and be ready to work fully onsite.Key Responsibilities:Conduct commissioning, qualification, and validation activities for pharmaceutical manufacturing equipment and systems.Develop and...
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Mechanical Engineer Position
2 weeks ago
New York, New York, United States gpac Full timeMechanical Engineer OpportunityA well-established manufacturer is seeking an experienced Mechanical Engineer to contribute to their growth.Key Responsibilities:Develop new product concepts and enhance existing products by managing engineering project activities and priorities, collaborating with sales, manufacturing, sourcing, and quality teams.Apply...
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Software Engineer
3 days ago
New York, New York, United States Mphasis Full timeJob Summary:As a Software Developer at Mphasis, you will be responsible for analyzing software requirements, developing software, modifying, and maintaining software systems. You will also develop data migration tools and new code to meet users' requirements. Additionally, you will assist in developing validation procedures, setting up test environments and...