Summary: We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted ...
Katalyst
60 jobs near Princeton, NJ
Summary: We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted ...
Responsibilities: * Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments)
Responsibilities: * Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments)
QUALITY ENGINEER II
$75.20K - $97.20K/yr
As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of Quality ...
QUALITY ENGINEER II
$75.20K - $97.20K/yr
As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of Quality ...
CSV Consultant
Raritan, NJ · Remote
Job Summary: * CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches.
CSV Consultant
Raritan, NJ · Remote
Job Summary: * CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches.
Roles & Responsibilities: * Previous C&Q experience, Clean Utility Qualification experience mandatory * Can work independently * Works with a sense a urgently * Organized * Flexible to support ...
Roles & Responsibilities: * Previous C&Q experience, Clean Utility Qualification experience mandatory * Can work independently * Works with a sense a urgently * Organized * Flexible to support ...
Required Skills: * Excellent customer service skills complemented by an ability to listen to and interpret client requests * Ability to troubleshoot complex instrument and technology issues * Strong ...
Required Skills: * Excellent customer service skills complemented by an ability to listen to and interpret client requests * Ability to troubleshoot complex instrument and technology issues * Strong ...
Summary: * We are seeking a Commissioning Engineer to join one of our largest pharmaceutical clients 5x/week onsite in Rensselaer, NY. This individual will be joining the engineering team within the ...
Summary: * We are seeking a Commissioning Engineer to join one of our largest pharmaceutical clients 5x/week onsite in Rensselaer, NY. This individual will be joining the engineering team within the ...
CSV Engineer
Raritan, NJ · Hybrid
Job Summary: * The CSV Engineer will be responsible for validating Windchill and Product Lifecycle Management (PLM) systems in an FDA and/or globally regulated environment. * This role requires ...
CSV Engineer
Raritan, NJ · Hybrid
Job Summary: * The CSV Engineer will be responsible for validating Windchill and Product Lifecycle Management (PLM) systems in an FDA and/or globally regulated environment. * This role requires ...
IT Project Manager
South Plainfield, NJ · Hybrid
$102.90K - $121.70K/yr
The IT Project Manager is responsible for planning, leading, and delivering IT projects on time, within scope, and within budget. The role works with global teams and manages IT application projects ...
IT Project Manager
South Plainfield, NJ · Hybrid
$102.90K - $121.70K/yr
The IT Project Manager is responsible for planning, leading, and delivering IT projects on time, within scope, and within budget. The role works with global teams and manages IT application projects ...
Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international ...
Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international ...
CSV Engineer
Raritan, NJ · Remote
$105K - $138.20K/yr
Roles & Responsibilities * Lead end-to-end CSV activities (inventory assessment remediation disposition) * Support business separation for large GxP systems * Define & implement risk-based validation ...
CSV Engineer
Raritan, NJ · Remote
$105K - $138.20K/yr
Roles & Responsibilities * Lead end-to-end CSV activities (inventory assessment remediation disposition) * Support business separation for large GxP systems * Define & implement risk-based validation ...
We are seeking a highly motivated and detail-oriented Clinical Data Manager to join our dynamic clinical research team. In this pivotal role, you will oversee the collection, management, and ...
We are seeking a highly motivated and detail-oriented Clinical Data Manager to join our dynamic clinical research team. In this pivotal role, you will oversee the collection, management, and ...
Embedded SW Engineer (C with AUTOSAR)
$137.40K - $180.80K/yr
Roles and responsibilities: * Responsible for the development, configuration and testing of signal processing and diagnostic algorithms used in embedded systems for machine and industrial ...
Embedded SW Engineer (C with AUTOSAR)
$137.40K - $180.80K/yr
Roles and responsibilities: * Responsible for the development, configuration and testing of signal processing and diagnostic algorithms used in embedded systems for machine and industrial ...
Senior Business Analyst
$96.70K - $124.90K/yr
Summary * We are seeking a highly skilled Senior Business Analyst to lead the rebuilding of LabVantage integrations with SAP and design new integrations to support critical business processes. The ...
Senior Business Analyst
$96.70K - $124.90K/yr
Summary * We are seeking a highly skilled Senior Business Analyst to lead the rebuilding of LabVantage integrations with SAP and design new integrations to support critical business processes. The ...
IT Manufacturing Support
$22 - $30.25/hr
Summary: * Support patch management, antivirus updates, and Windows/server maintenance for lab PCs and software systems in coordination with IT infrastructure teams. * Demonstrated experience in ...
IT Manufacturing Support
$22 - $30.25/hr
Summary: * Support patch management, antivirus updates, and Windows/server maintenance for lab PCs and software systems in coordination with IT infrastructure teams. * Demonstrated experience in ...
The Design Quality Engineer (DQE) at Philips is responsible for ensuring that products are designed and developed in compliance with regulatory standards, quality requirements, and customer ...
The Design Quality Engineer (DQE) at Philips is responsible for ensuring that products are designed and developed in compliance with regulatory standards, quality requirements, and customer ...
Roles & Responsibilities: * Must have basic knowledge or understanding of Pharmaceutical/Medical Device compliances like 21 CFR Part 11 Compliance, GAMP, GDP etc . * Previous work experience in MES ...
Roles & Responsibilities: * Must have basic knowledge or understanding of Pharmaceutical/Medical Device compliances like 21 CFR Part 11 Compliance, GAMP, GDP etc . * Previous work experience in MES ...
Roles & Responsibilities: * Proficiency in CAD (SolidWorks/Creo). GD&T tolerance analysts, and fixture design. * Knowledge of orthopedic testing standards (ASTM F382 F543, F1717. F2077,150 14242 ...
Roles & Responsibilities: * Proficiency in CAD (SolidWorks/Creo). GD&T tolerance analysts, and fixture design. * Knowledge of orthopedic testing standards (ASTM F382 F543, F1717. F2077,150 14242 ...
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent ...
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent ...
* Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards (21 CFR Part 11, Annex 11). * Review audit trails ...
* Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards (21 CFR Part 11, Annex 11). * Review audit trails ...
Other
Posted 10 days ago
Job description
Summary:
We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring our cloud infrastructure meets regulatory compliance standards (e.g., GxP, HIPAA, ISO 27001) through robust validation and documentation practices.
Roles & Responsibilities:
Education & Experience :
We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring our cloud infrastructure meets regulatory compliance standards (e.g., GxP, HIPAA, ISO 27001) through robust validation and documentation practices.
- Develop and maintain IQ/OQ/PQ documentation for AWS infrastructure components.
- Collaborate with DevOps and Cloud Engineering teams to understand architecture and deployment models.
- Ensure infrastructure is validated according to GAMP 5 and Computer System Validation (CSV) principles.
- Create and manage traceability matrices, risk assessments, and validation plans.
- Support internal and external audits by providing documentation and evidence of compliance.
- Maintain version-controlled documentation repositories (e.g., SharePoint, Confluence).
- Define and implement automated validation checks using tools like Chef InSpec or AWS Config.
- Stay updated with AWS service changes and assess their impact on validated environments.
- Bachelor's degree in Computer Science, Information Systems, or related field.
- 5+ years of experience in cloud infrastructure, preferably AWS.
- 3+ years in validation or compliance documentation in regulated industries.
- Strong understanding of AWS services: EC2, S3, RDS, IAM, VPC, CloudTrail, CloudWatch.
- Experience with Infrastructure as Code (IaC) tools: Terraform, CloudFormation.
- Familiarity with GxP, GAMP 5, HIPAA, or ISO 27001 compliance frameworks.
- Excellent written communication and documentation skills.
- Experience with audit processes and regulatory inspections.