* We are looking for an experienced professional who will be responsible for the administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process ...
Katalyst
32 jobs near San Francisco, CA
* We are looking for an experienced professional who will be responsible for the administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process ...
Senior CQV Engineer
$123.10K - $169.10K/yr
Roles & Responsibilities : * Lead smoke studies, including airflow visualization and identifying stagnant air or pass-through airflow issues. * Support pressurization challenge studies and evaluate ...
Senior CQV Engineer
$123.10K - $169.10K/yr
Roles & Responsibilities : * Lead smoke studies, including airflow visualization and identifying stagnant air or pass-through airflow issues. * Support pressurization challenge studies and evaluate ...
Responsibilities: * We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. * You will work collaboratively with other functional ...
Responsibilities: * We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. * You will work collaboratively with other functional ...
V&V Engineer
$101K - $124.20K/yr
Job Summary: * The System Verification & Validation (V&V) Engineer is responsible for executing system-level verification and validation activities to ensure requirements traceability, regulatory ...
V&V Engineer
$101K - $124.20K/yr
Job Summary: * The System Verification & Validation (V&V) Engineer is responsible for executing system-level verification and validation activities to ensure requirements traceability, regulatory ...
Design, build, and configure clinical study databases in EDC/CDM platforms. Ensure systems meet client needs, follow GCDMP, support accurate data capture, workflows, edit checks, and integrations.
Design, build, and configure clinical study databases in EDC/CDM platforms. Ensure systems meet client needs, follow GCDMP, support accurate data capture, workflows, edit checks, and integrations.
Responsibilities: * Develop and execute U.S. regulatory strategies to support product submissions (e.g., IDE, 510(k), De Novo) and post-market requirements. * Serve as the primary point of contact ...
Responsibilities: * Develop and execute U.S. regulatory strategies to support product submissions (e.g., IDE, 510(k), De Novo) and post-market requirements. * Serve as the primary point of contact ...
Responsibilities: * Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with Quality Management System (QMS) expectations.
Responsibilities: * Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with Quality Management System (QMS) expectations.
Responsibilities: * Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. * Attends congress and reviews ...
Responsibilities: * Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. * Attends congress and reviews ...
Responsibilities: * Support preparation, review, and submission of CMC sections for U.S and global regulatory filings (INDs/CTAs, amendments, and BLAs/MAAs). * Coordinate with internal stakeholders ...
Responsibilities: * Support preparation, review, and submission of CMC sections for U.S and global regulatory filings (INDs/CTAs, amendments, and BLAs/MAAs). * Coordinate with internal stakeholders ...
Responsibilities: * This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product ...
Responsibilities: * This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product ...
Sr. Development Quality Engineer
$98.30K - $133.30K/yr
You'll serve as a technical quality leader within a product development team, ensuring patient safety, product reliability, and full regulatory compliance across all phases of development.
Sr. Development Quality Engineer
$98.30K - $133.30K/yr
You'll serve as a technical quality leader within a product development team, ensuring patient safety, product reliability, and full regulatory compliance across all phases of development.
We are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design changes, and ...
We are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design changes, and ...
Quality Engineer
$84.80K - $109.60K/yr
Job Summary: We are seeking an Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device ...
Quality Engineer
$84.80K - $109.60K/yr
Job Summary: We are seeking an Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device ...
Responsibilities: * Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical ...
Responsibilities: * Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical ...
Summary: We are seeking a highly skilled Data Integrity SME with a strong Quality Assurance background and hands-on experience in analytical equipment documentation within the pharmaceutical industry.
Summary: We are seeking a highly skilled Data Integrity SME with a strong Quality Assurance background and hands-on experience in analytical equipment documentation within the pharmaceutical industry.
Responsibilities: * Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. * Oversee Data Management activities from study start-up to close-out.
Responsibilities: * Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. * Oversee Data Management activities from study start-up to close-out.
Responsibilities: * Lead the data quality evaluation by investigating all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports. * Manage high ...
Responsibilities: * Lead the data quality evaluation by investigating all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports. * Manage high ...
Sr. Development Quality Engineer
$97.80K - $132.60K/yr
The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative ...
Sr. Development Quality Engineer
$97.80K - $132.60K/yr
The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative ...
Summary: We are looking for a skilled CSV Engineer with strong experience in Veeva systems to support validation, compliance, and implementation activities in a regulated life sciences environment.
Summary: We are looking for a skilled CSV Engineer with strong experience in Veeva systems to support validation, compliance, and implementation activities in a regulated life sciences environment.
Job Summary: * We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS ...
Job Summary: * We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS ...
Job description
Job Description:
- We are looking for an experienced professional who will be responsible for the administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems.
- The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations.
- This role focuses on deploying system updates, administering system security, resolving technical issues, and ensuring system reliability under the direction of a System Manager.
- Perform periodic system maintenance activities such as System Maintenance, Server Maintenance, System Audit Trail Review, User access reviews and coordinating with IT and drive completion of server maintenance.
- Monitor system performance, identifying bottlenecks and working with system manager to implement solutions to optimize system UI/UX. Perform periodic system health checks.
- Validate compatibility of OS patches with the application and co-ordinate with IT for installation of patches and perform post-patch verification testing on a periodic basis.
- Work with the System Manager to evaluate application patches on a periodic basis, perform installation of approved patches and assist Validation Engineers in regression testing following patch installation.
- Administering system security and access control such as creating, managing and updating user accounts within the system environments per applicable procedures.
- Collaborating with the System Manager to create and maintain training content and provide training to users requesting access.
- Troubleshoot and resolve hardware, software issues and collaborate with IT to resolve network-related issues impacting system availability and performance.
- Provide technical support during change management and assist automation engineers and/or system integrators in deploying changes to systems.
- Provide technical support for validation engineers performing annual backup and restore testing as well as disaster recovery testing.
- Assist validation engineers in installation, operational and performance testing as well as perform IQ/OQ/PQ testing, when required.
- Bachelor's degree in computer science, Engineering, Industrial Automation, Information Technology, or a related field (or equivalent experience).
- Minimum of 3-5 years of experience administering or integrating process control systems, specifically. Rockwell FactoryTalk-based systems and/or Inductive Automation's Ignition-based systems.
- Experience interfacing with PLCs, SCADA, or historian systems.
- Excellent communication skills and the ability to work collaboratively with technical and non-technical teams.
- Experience deploying and configuring systems in a production environment. Strong troubleshooting skills with the ability to diagnose and resolve complex technical issues efficiently.
- Demonstrated experience working in a GMP-regulated environment with a thorough understanding of FDA regulations (e.g., 21 CFR Part 11).
- Familiarity with system validation, change control, and documentation practices in a regulated setting.
- Experience in authoring and executing change control for implemented GMP systems.
- Ability to prioritize tasks and manage multiple responsibilities in a fast-paced environment.
- Keen attention to detail and a commitment to maintaining compliance with regulatory standards.