21 - 40 of 52 Jobs

CQV Engineer

Katalyst Healthcares and Lifesciences

Holly Springs, North Carolina, USA

Full-time

Responsibilities: Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC). Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis. Supporting clients change management program - including authoring proposed changes, executing impact assessments/ regression analysis,

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's

Validation Engineer

Katalyst Healthcares and Lifesciences

Santa Clara, California, USA

Full-time

Roles & Responsibilities: Software quality assurance or software validation. Preferably within the medical device industry. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304. Experience in non-product software validation. Includes tools for development, testing, maintenance. Deep understanding of quality standards and regulatory requirements: FDA 21 CFR Part 820. ISO 13485. IEC 62304. Software quality assurance. Software validation. Non-product software tools (for testing

Validation Engineer

Salas O'Brien Engineers Incorporated

Houston, Texas, USA

Full-time

At Salas O'Brien we tell our clients that we're engineered for impact. This passion for making a difference applies just as much to our team as it does to our projects. That's why we're committed to living our values every day: inspiring, achieving, and connecting as shared owners of our success with a focus on a sustainable future. Building for the long-term means that all of our team members can expect to work on amazing projects with a people-first approach to problem solving. It also means

Controls Engineer

Merck KgaA

Jaffrey, New Hampshire, USA

Full-time

Work Location: Jaffrey, New Hampshire Shift: No Department: LS-SC-PEJBAH Jaffrey Controls Engineering Recruiter: Katherine Hall Hiring Manager: Lemuel Gomez This information is for internals only. Please do not share outside of the organization. Your Role: In this role you are primarily responsible for providing innovative automated solutions through collaboration with equipment suppliers and internal colleagues. In this role you will be handling multiple projects at the same time, be hands o

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

Kansas City, Missouri, USA

Full-time

Responsibilities: Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) Experience in validating GMP Lab systems and Equipment. Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project. Identify and escalate, as necessary project risks and issues to the CSVC Manager. Engage

Commissioning & Qualification (C&Q) Engineer

Katalyst Healthcares and Lifesciences

Harrisburg, Pennsylvania, USA

Full-time

Responsibilities: Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities. Perform system startup, debugging, and initial testing of process and utility systems. Ensure that systems are installed and operating according to design specifications. Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning. Review and verify system documentation, such as P&IDs, wiring diagrams, and datashee

Cardiovascular Data Scientist

University Of Utah

Salt Lake City, Utah, USA

Full-time

Posting Details The University of Utah, an AA/EO employer, encourages applications from all qualified individuals, and provides reasonable accommodation to the known disabilities of applicants and employees. The University of Utah values candidates who have experience working in settings with students, staff, faculty and patients from all backgrounds and possess a strong commitment to improving access to higher education, employment opportunities, and quality healthcare for historically underre

CSV Engineer

Katalyst Healthcares and Lifesciences

Jacksonville, Florida, USA

Full-time

Responsibilities: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews. Review and approve internal and vendor software packages and test documentation. Prioritize and plan all assigned projects for the software validation departm

LIMS Master Data Specialist

Katalyst Healthcares and Lifesciences

Summit, New Jersey, USA

Full-time

Position Summary: Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement. Responsibilities: Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers. Provide electronic systems operational support and troubleshooting to end use

Validation Engineer

Katalyst Healthcares and Lifesciences

Thousand Oaks, California, USA

Full-time

Responsibilities: Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines. Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment. Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equi

Sr. Software Quality Engineer (CSV)

Katalyst Healthcares and Lifesciences

Texas, USA

Full-time

Responsibilities: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews. Review and approve internal and vendor software packages and test documentation. Prioritize and plan all assigned projects for the software validation departm

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

Applications Systems Analyst

University Of Utah

Salt Lake City, Utah, USA

Full-time

Announcement Details Open Date 06/24/2025 Requisition Number PRN42294B Job Title Applications Systems Analyst Working Title BMIC Applications Systems Analyst Job Grade F FLSA Code Computer Employee Patient Sensitive Job Code? No Standard Hours per Week 30 Full Time or Part Time? Full Time Shift Day Work Schedule Summary Arranged with the Supervisor VP Area U of U Health - Academics Department 01271 - Biomed Informatics Core CCTS Location Campus City Salt Lake City, UT Type of Rec

Equipment and Automation Controls Engineer

Katalyst Healthcares and Lifesciences

Atlanta, Georgia, USA

Full-time

Job Description: We are seeking a highly skilled Equipment and Automation Controls Engineer to join our team. This role involves designing, implementing, installing, analyzing and/or optimizing manufacturing processes, procedures, equipment, and programming. The ideal candidate will also have expertise in PLC and automation controls, ensuring seamless integration and functionality of mechatronic systems to best support our 24/7 operation. Responsibilities: Manufacturing Process Improvements: Le

Systems Administrator

University Of Utah

Remote or Salt Lake City, Utah, USA

Full-time

Announcement Details Open Date 06/13/2025 Requisition Number PRN42189B Job Title Systems Administrator Working Title Marketing Automation Specialist Job Grade F FLSA Code Computer Employee Patient Sensitive Job Code? No Standard Hours per Week 40 Hours Full Time or Part Time? Full Time Shift Day Work Schedule Summary This is a remote position VP Area Academic Affairs Department 02218 - Data and Software Solutions Location Other City Salt Lake City, UT Type of Recruitment Externa

C&Q Engineer - (Commissioning & Qualification) || Harrisburg, PA (Onsite)

Stellent IT LLC

Harrisburg, Pennsylvania, USA

Contract, Third Party

Position: C&Q Engineer Location: Harrisburg, PA (Onsite) Duration: 12+ month contract Multiple Openings - Standard C&Q profile ideally with 7+ years' experience. More experience the better Job Description :- We are looking for a highly skilled Senior Commissioning & Qualification (C&Q) Engineer to support our Life Sciences projects. The ideal candidate will have extensive experience in qualification and validation activities, ensuring compliance with industry regulations and best practices.

IT Product Manager Sr

University Of Utah

Salt Lake City, Utah, USA

Full-time

Announcement Details Open Date 04/24/2025 Requisition Number PRN41720B Job Title IT Product Manager Sr Working Title AI Product Manager Job Grade H FLSA Code Computer Employee Patient Sensitive Job Code? No Standard Hours per Week 40 Full Time or Part Time? Full Time Shift Day Work Schedule Summary Hybryd work schedule (few days in office; few - remote) Monday - Friday 8 am to 5pm VP Area President Department 00428 - UIT - Network & Comm. Srvs Location Campus City Salt Lake City,

Operational Technology (OT) Engineer

Becton Dickinson & Company

El Paso, Texas, USA

Full-time

Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human e

Data Architect

University Of Utah

Salt Lake City, Utah, USA

Full-time

Announcement Details Open Date 07/22/2025 Requisition Number PRN42622B Job Title Data Architect Working Title Data Architect Job Grade G FLSA Code Computer Employee Patient Sensitive Job Code? No Standard Hours per Week 40 Full Time or Part Time? Full Time Shift Day Work Schedule Summary Monday-Friday; 8:30am - 5:30 pm VP Area U of U Health - Academics Department 02228 - Data Coordinating Center Location Campus City Salt Lake City, UT Type of Recruitment External Posting Pay Rat