Summary : The main function of a Validation Engineer is to ensure that systems, equipment, and processes meet regulatory and performance standards through rigorous testing and documentation. A ...
Katalyst
76 jobs near Medina, WA
Summary : The main function of a Validation Engineer is to ensure that systems, equipment, and processes meet regulatory and performance standards through rigorous testing and documentation. A ...
Summary : We are seeking an experienced Validation Engineer to support pharmaceutical manufacturing and quality operations in Washington. The ideal candidate will have hands-on experience in ...
Summary : We are seeking an experienced Validation Engineer to support pharmaceutical manufacturing and quality operations in Washington. The ideal candidate will have hands-on experience in ...
CSV Engineer
$81.80K - $105.70K/yr
Summary: * 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 ...
CSV Engineer
$81.80K - $105.70K/yr
Summary: * 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 ...
Baxter is seeking a Sr. Principal Software Quality Engineer with 8+ years of progressive experience in medical device Quality Engineering, supporting both hardware and software development. This role ...
Baxter is seeking a Sr. Principal Software Quality Engineer with 8+ years of progressive experience in medical device Quality Engineering, supporting both hardware and software development. This role ...
* You are responsible for managing activities related to post-market product safety surveillance and risk management. * Serves as a liaison between Medical Affairs, Clinical Affairs, Research ...
New
* You are responsible for managing activities related to post-market product safety surveillance and risk management. * Serves as a liaison between Medical Affairs, Clinical Affairs, Research ...
New
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 ...
* You are responsible for managing activities related to post-market product safety surveillance and risk management. * Serves as a liaison between Medical Affairs, Clinical Affairs, Research ...
* You are responsible for managing activities related to post-market product safety surveillance and risk management. * Serves as a liaison between Medical Affairs, Clinical Affairs, Research ...
Responsibilities: * To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and ...
Responsibilities: * To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and ...
We are looking for a Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist provides leadership and input on company strategies and programs involving regulatory and ...
We are looking for a Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist provides leadership and input on company strategies and programs involving regulatory and ...
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 ...
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 ...
Summary : Roles & Responsibilities : • Work with Material Review Board (MRB) to review and process QNs. • Generate supplier quality notifications (SQNs) and send them to suppliers. • As ...
Summary : Roles & Responsibilities : • Work with Material Review Board (MRB) to review and process QNs. • Generate supplier quality notifications (SQNs) and send them to suppliers. • As ...
Quality & Regulatory / Post-Market Surveillance
$81.60K - $105.40K/yr
We are seeking a skilled Risk & Health Hazard Evaluation (HHE) Specialist to support CAPA and post-market activities for ultrasound systems. This role is critical in ensuring patient safety ...
Quality & Regulatory / Post-Market Surveillance
$81.60K - $105.40K/yr
We are seeking a skilled Risk & Health Hazard Evaluation (HHE) Specialist to support CAPA and post-market activities for ultrasound systems. This role is critical in ensuring patient safety ...
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate ...
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate ...
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 ...
Summary: * The Computer Systems Validation (CSV) works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. * This role is an individual ...
Summary: * The Computer Systems Validation (CSV) works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. * This role is an individual ...
Director of Engineering, Spacecraft
Broomfield, CO · On-site
$195K - $260K/yr
Katalyst Description: We build robotic spacecraft that enable dynamic space operations, creating a future where maneuvering, upgrading, refueling, and exploration are as routine as they are on Earth.
Director of Engineering, Spacecraft
Broomfield, CO · On-site
$195K - $260K/yr
Katalyst Description: We build robotic spacecraft that enable dynamic space operations, creating a future where maneuvering, upgrading, refueling, and exploration are as routine as they are on Earth.
Director of Engineering, Spacecraft
$195K - $260K/yr
Establish the technical baseline for Katalyst's robotic spacecraft. * Translate work completed into a defined, repeatable system architecture. * Identify, define, and formalize interface and ...
Director of Engineering, Spacecraft
$195K - $260K/yr
Establish the technical baseline for Katalyst's robotic spacecraft. * Translate work completed into a defined, repeatable system architecture. * Identify, define, and formalize interface and ...
Quality Engineer
Broomfield, CO · On-site
$110K - $145K/yr
Katalyst Description: We build robotic spacecraft that enable dynamic space operations, creating a future where maneuvering, upgrading, refueling, and exploration are as routine as they are on Earth.
Quality Engineer
Broomfield, CO · On-site
$110K - $145K/yr
Katalyst Description: We build robotic spacecraft that enable dynamic space operations, creating a future where maneuvering, upgrading, refueling, and exploration are as routine as they are on Earth.
Senior Navigation Engineer, Spacecraft
Broomfield, CO · On-site
$150K - $200K/yr
Katalyst Description: We build robotic spacecraft that enable dynamic space operations, creating a future where maneuvering, upgrading, refueling, and exploration are as routine as they are on Earth.
Senior Navigation Engineer, Spacecraft
Broomfield, CO · On-site
$150K - $200K/yr
Katalyst Description: We build robotic spacecraft that enable dynamic space operations, creating a future where maneuvering, upgrading, refueling, and exploration are as routine as they are on Earth.
Job description
Summary :
The main function of a Validation Engineer is to ensure that systems, equipment, and processes meet regulatory and performance standards through rigorous testing and documentation. A typical Validation Engineer develops protocols, executes validation activities, and supports compliance across manufacturing or research environments.
Manager provided responsibilities for the role.
The main function of a Validation Engineer is to ensure that systems, equipment, and processes meet regulatory and performance standards through rigorous testing and documentation. A typical Validation Engineer develops protocols, executes validation activities, and supports compliance across manufacturing or research environments.
Manager provided responsibilities for the role.
- Provide lifecycle management for Quality Control lab instruments and related software systems.
- Revise and/or obsolete validation documents and Standard Operating Procedures (SOPs).
- Provide validation services for laboratory analytical instruments and controlled temperature units (CTU) to include writing, editing, executing protocols, and reviewing vendor validation documents in accordance with site requirements for validation activities.
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4. Perform change control management activities: authoring, performing, and tracking of change actions - Creating and performing investigations for Deviations/CAPAs
- Perform instrument periodic reviews
Roles & Responsibilities:
- Design and execute validation protocols (IQ/OQ/PQ) for equipment, utilities, and processes Analyze test data and determine whether systems meet predefined acceptance criteria Document validation activities and maintain records in accordance with regulatory guidelines Collaborate with cross-functional teams to support product development and process improvements Investigate deviations and implement corrective and preventive actions (CAPAs) Ensure compliance with industry standards such as FDA, ISO, and cGMP Participate in audits and inspections, providing validation documentation and responses Stay current with validation trends, technologies, and regulatory update
Education & Experience :
- Strong analytical and problem-solving abilities Knowledge of validation principles, quality systems, and regulatory requirements Proficiency in statistical analysis tools and validation software Excellent written and verbal communication skills Ability to work independently and manage multiple projects Familiarity with laboratory and manufacturing environments
- Bachelor's degree in Engineering, Life Sciences, or a related field required 5-7 years of experience in validation, quality assurance, or process engineering