Validation Lead
4 weeks ago
"Strong expertise in Computer System Validation (CSV) processes and methodologies, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11, GxP, and healthcare-specific requirements.
Proficiency in validating SAP systems and associated healthcare applications, including creating and executing validation plans, protocols, and reports (IQ, OQ, PQ).
In-depth knowledge of healthcare regulatory compliance, including HIP nd other industry standards, to ensure validated systems meet operational and legal requirements.
Experience in risk-based validation approaches, focusing on critical system functionalities and maintaining compliance while optimizing validation efforts.
Strong understanding of SAP healthcare modules (e.g., MM, SD, FICO, EHS) and their integration with other systems to design effective validation strategies.
Excellent problem-solving skills to identify, document, and resolve validation issues, ensuring systems operate reliably and meet compliance standards.
Effective communication and collaboration skills to work with cross-functional teams, including quality assurance, IT, and business stakeholders, to ensure successful validation processes."
"Develop and execute comprehensive Computer System Validation (CSV) plans, protocols (IQ, OQ, PQ), and reports to ensure SAP systems and associated healthcare applications meet regulatory and operational requirements.
Ensure compliance with healthcare industry regulations, including FDA 21 CFR Part 11, GxP, and HIPAA, by validating system functionalities and documentation processes.
Collaborate with cross-functional teams, including IT, quality assurance, and business stakeholders, to define validation requirements and implement risk-based validation strategies.
Perform detailed validation activities, including system testing, user acceptance testing (UAT), and documentation of test results, ensuring systems function as intended in a healthcare environment.
Identify and resolve validation issues, conducting root cause analyses and implementing corrective actions to maintain compliance and system reliability.
Provide training and guidance on CSV processes to stakeholders, ensuring understanding and adherence to validation standards and best practices.
Stay updated on healthcare regulations and validation trends, advising on improvements to validation strategies and ensuring the organization's systems remain compliant and efficient.
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Validation Expert
3 weeks ago
Rahway, New Jersey, United States Tekfortune Inc Full timeJob TitleValidation LeadAbout the RoleWe are seeking an experienced Validation Lead to join our team at Tekfortune Inc. As a key member of our validation team, you will be responsible for ensuring that our SAP systems and associated healthcare applications meet regulatory and operational requirements.Key ResponsibilitiesDevelop and execute comprehensive...
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SAP Healthcare Validation Specialist
2 days ago
Rahway, New Jersey, United States Laiba Technologies Full timeAt Laiba Technologies, we are seeking a highly skilled SAP Healthcare Validation Specialist to join our team.Job Description:This role involves validating SAP systems and associated healthcare applications to ensure compliance with regulatory standards such as FDA 21 CFR Part 11, GxP, and healthcare-specific requirements.Key Responsibilities:Validating SAP...
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Rahway, United States Merck Sharp & Dohme (MSD) Full timeJob DescriptionOur company’s Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our company’s pipeline of...
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Rahway, United States Merck Sharp & Dohme (MSD) Full timeJob DescriptionOur company’s Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our company’s pipeline of...
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Rahway, United States Merck Sharp & Dohme (MSD) Full timeJob DescriptionOur company’s Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our company’s pipeline of...
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Operational Crew Lead
5 days ago
Rahway, New Jersey, United States Disability Solutions Full timeJob Description">As a Driver/Operator A Dry at Disability Solutions, you will play a critical role in ensuring the safe and efficient operation of equipment, including heavy-duty vehicles. This position requires a highly skilled and safety-focused individual who can meet the demands of this role.">Main Responsibilities"> Operate heavy-duty vehicles safely...
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Clinical Trials Specialist
1 day ago
Rahway, New Jersey, United States Net2Source Inc. Full timeNet2Source Inc. is a global leader in the provision of specialized services to the pharmaceutical industry. Our direct client is seeking a highly skilled Research Scientist Assistant to join their team.Key responsibilities will include:• Utilizing advanced technologies such as Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectrometry and...
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Translational Research Scientist
2 weeks ago
Rahway, United States Integrated Resources, Inc ( IRI ) Full timePosition Description: Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectrometry and Genomics, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of clinical development at Client Research Laboratories. Candidate should have a strong...
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Outcomes Research Manager
3 weeks ago
Rahway, New Jersey, United States Collabera Full timeAbout the RoleThis is an exciting opportunity for a results-driven Outcomes Research Manager to lead the development and validation of clinical outcomes assessments. The successful candidate will possess a Master's Degree in Health Services Research, Statistics, or a closely related field, along with 5+ years of relevant industry experience.
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Scientist - Immunoassay
2 weeks ago
Rahway, United States Integrated Resources, Inc ( IRI ) Full timePosition Description: Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectrometry and Genomics, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of clinical development at Client Research Laboratories. Candidate should have a strong...
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Principal Investigator in Medicinal Sciences
3 days ago
Rahway, New Jersey, United States MSD Malaysia Full timeOur company is seeking a highly skilled Director of Chemistry Research to lead our multidisciplinary team in developing innovative medicinal chemistry solutions. As a seasoned expert in medicinal chemistry design principles, you will drive project strategy and execution from target validation through to preclinical candidate selection.You will be responsible...
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Director of Manufacturing Compliance
1 day ago
Rahway, New Jersey, United States Blackwomenintech Full timeCompany OverviewWe strive to provide innovative solutions that improve people's lives. Our commitment to quality and regulatory compliance is unwavering, ensuring that our products meet the highest standards of safety and efficacy.The Senior Director of Engineering Excellence will be instrumental in driving this vision forward, leading the Quality...
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Senior Director of Engineering Excellence
2 days ago
Rahway, New Jersey, United States Blackwomenintech Full timeAbout UsWe are committed to delivering high-quality products that meet our customers' needs. Our organization has a strong focus on quality and regulatory compliance, ensuring that our products are safe and effective.The Senior Director of Engineering Excellence will play a critical role in leading our Quality Engineering Department, overseeing maintenance,...
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iConsultera | Translational Research Scientist
2 weeks ago
rahway, United States iConsultera Full timeTitle: Translational Research Scientist - ILocation: Rahway, NJDuration: 12 MonthsPosition Description: Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectrometry and Genomics, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of clinical...
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Translational Research Scientist
3 weeks ago
rahway, United States TalentBurst Full timeTitle: Translational Research Scientist - I Location: Rahway, NJ Duration: 12+ months Position Description: Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectrometry and Genomics, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of...
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TalentBurst | Translational Research Scientist
3 weeks ago
rahway, United States TalentBurst Full timeTitle: Translational Research Scientist - I Location: Rahway, NJ Duration: 12+ months Position Description: Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectrometry and Genomics, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of...
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Translational Research Scientist
2 weeks ago
Rahway, United States iConsultera Full timeTitle: Translational Research Scientist - ILocation: Rahway, NJDuration: 12 MonthsPosition Description: Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectrometry and Genomics, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of clinical...
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Translational Research Scientist
2 weeks ago
Rahway, United States iConsultera Full timeTitle: Translational Research Scientist - ILocation: Rahway, NJDuration: 12 MonthsPosition Description: Utilizing the technologies of Flow Cytometry, Molecular Pathology, Immunochemistry, Mass Spectrometry and Genomics, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of clinical...
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Senior Scientist
2 weeks ago
Rahway, United States Net2Source Inc. Full timeJob title: Translational Research Scientist - I Location: Rahway NJ 07065 Duration: 12 monthsPay rate: $53.75/hoursMust haves:• Cell Culture, • Cell sorting, • Flow cytometry, • In vivo experiments, • Immunoassays (ELISA, MSD etc) • Strong Biomarker assays. Position Description:Utilizing the technologies of Flow Cytometry, Molecular Pathology,...
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rahway, United States Pyramid Consulting, Inc Full timeImmediate need for a talented Translational Research Scientist - I. This is a 12+ months contract opportunity with long-term potential and is located in Rahway, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 24-54529 Pay Range: $48 - $53/hour. Employee benefits include, but are not limited to, health...
