* 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
120 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 ...
Summary: * With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and ...
Summary: * With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and ...
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 ...
Manufacturing Engineer
$82.20K - $105.90K/yr
Job Summary: * Manufacturing Engineer with 3-4 years of experience in the medical device manufacturing industry, specializing in supporting regulated production environments. * Experienced in ...
Manufacturing Engineer
$82.20K - $105.90K/yr
Job Summary: * Manufacturing Engineer with 3-4 years of experience in the medical device manufacturing industry, specializing in supporting regulated production environments. * Experienced in ...
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 ...
Manufacturing Engineer
$83.20K - $107.20K/yr
Job Summary: * Study and evaluate current manufacturing practices and identify efficiency improvements * Act as the primary technical authority for manufacturing processes, designs, and equipment.
Manufacturing Engineer
$83.20K - $107.20K/yr
Job Summary: * Study and evaluate current manufacturing practices and identify efficiency improvements * Act as the primary technical authority for manufacturing processes, designs, and equipment.
Job Summary: * As a Computer System Validation (CSV) Engineer in the pharmaceutical industry, this role is responsible for ensuring that computer-based systems such as Manufacturing Execution Systems ...
Job Summary: * As a Computer System Validation (CSV) Engineer in the pharmaceutical industry, this role is responsible for ensuring that computer-based systems such as Manufacturing Execution Systems ...
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.
Material Handler 3
$19 - $23/hr
Material Handler III is responsible for the safe, accurate loading and unloading of product within the distribution centre. Uses ERP systems requiring location and storage of items, proper packaging ...
Material Handler 3
$19 - $23/hr
Material Handler III is responsible for the safe, accurate loading and unloading of product within the distribution centre. Uses ERP systems requiring location and storage of items, proper packaging ...
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 ...
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 ...
Material Handler 3
$19 - $23/hr
Material Handler III is responsible for the safe, accurate loading and unloading of product within the distribution centre. Uses ERP systems requiring location and storage of items, proper packaging ...
Material Handler 3
$19 - $23/hr
Material Handler III is responsible for the safe, accurate loading and unloading of product within the distribution centre. Uses ERP systems requiring location and storage of items, proper packaging ...
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: * 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: * With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP ...
Responsibilities: * With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP ...
Job Summary: The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. Each supplier ...
Job Summary: The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. Each supplier ...
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 ...
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 ...
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.
Global Trade Operations Specialist (CAB Team)
$56.30K - $75.40K/yr
Job Summary: We are seeking a Global Trade Operations Specialist to join the CAB Team in Santa Rosa, CA. This role will support global trade operations and work closely with cross-functional ...
Global Trade Operations Specialist (CAB Team)
$56.30K - $75.40K/yr
Job Summary: We are seeking a Global Trade Operations Specialist to join the CAB Team in Santa Rosa, CA. This role will support global trade operations and work closely with cross-functional ...
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.