41 - 60 of 106 Jobs

SUD Validation Engineer

Thermo Fisher Scientific

Logan, Utah, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so

Reliability Engineer

Cushman & Wakefield

Boston, Massachusetts, USA

Full-time

Job Title Reliability Engineer Job Description Summary This individual will provide support for GxP Facility Operations/Engineering department at Vertex GxP sites as part of the Reliability Engineering team. The ideal candidate will be responsible for ensuring the reliability and performance of our equipment/systems through Reliability best practices and continuous improvement initiatives. This role will also execute documentation/forms/spreadsheets to roll out Maintenance and Reliability Best

CQV Engineer

Katalyst Healthcares and Lifesciences

Pennsylvania, USA

Full-time

Responsibilities: The areas of focus will be on Cell Therapy and Temperature mapping. Preparation and execution of Qualification Protocols and Reports. Design Qualification (DQ). Installation Qualification (IQ). Operational Qualification (OQ). Performance Qualification (PQ). Review and/or authoring of supporting validation documentation. User Requirements Specifications (URS). Risk Assessments (e.g., SIA). Commissioning Test Report. Thermal mapping strategy definition and execution. Execution of

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

Sr. CSV Validation Lead/Engineer _ Bothell, WA ( Day1 onsite)

StarTechs Inc.

Bothell, Washington, USA

Third Party, Contract

Requirement details: Job Title: Sr. CSV Validation Lead/Engineer Location: Bothell, WA ( onsite) Duration : 12+ Months Job Description: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality is

CQV Engineers Needed - Spring House, PA_Onsite job

Stellent IT LLC

Spring House, Pennsylvania, USA

Third Party, Contract

Hiring for - TITLE - CQV Engineers - Spring House, PA_Onsite job They are going to need 25-30 CQV Engineers to assist on this project. Initial 6 12-month project. The areas of focus will be on Cell Therapy and Temperature mapping Need - LINEKDIN match with updated resume, no FAKE people Multiple CQV Engineers needed to support a project in Spring House, PA. The scope includes thermal mapping and qualification of various GMP equipment, with a strong focus on controlled temperature units and lab

Engineer, Engineering - Process (Days)

Novo Nordisk Inc

Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. T

BreakFix technician

Prism IT Corp

Georgia, USA

Contract, Third Party

Role- BreakFix technician Location- Newton County, Georgia Qualifications: Culture / Team fit Ambitious / Hard working / Go getter / Coachable / Mentor Physical layer: fiber optic connections, contamination, cleaning Understand ESD best practices Comfortable with text based CLI Familiar with IP based networking A+/Network+ level of knowledge required Good understanding of OSI layer and network principles 2+ years of DC experience required 4+ years of IT related experience required Familiarity wi

Networking Design Engineer Lead With Telecom Domain

Innominds Software

Mountain View, California, USA

Contract, Third Party

Networking Design Engineer Lead With Telecom Domain Location: Mountain View, CA (Hybrid) Duration: Long Term Experience: 15 Years Responsibilities: 15 years of experience in cellular and non-cellular telecom domains.Hands-on experience in TCP/IP, network routing and redundancy, and network tunnelling protocols.Hands-on experience with network connection aggregation technologies (e.g. LAG, LACP)Hands-on experience with configuration and optimizations of network hardware such as switches, router

DC Technician BreakFix || Henrico, VA***ONSITE***

Inherent Technologies

Henrico, Virginia, USA

Full-time, Part-time, Third Party, Contract

Role - : DC Technician BreakFix Location Henrico, VA Day 1 onsite Duration: 1 Years JD: DC technician BREAKFIX Qualifications: Physical layer: fiber optic connections, contamination, cleaning Understand ESD best practices Comfortable with text based CLI Familiar with IP based networking A+/Network+ level of knowledge required Good understanding of OSI layer and network principles 2+ years of DC experience required 4+ years of IT related experience required Familiarity with the Linux based s

Data Center Network Technician

Sira Consulting

Kansas City, Missouri, USA

Full-time, Part-time, Third Party, Contract

Role- Data Center Network Technician Location- Kansas City MO Duration 6+ Months Contract Qualifications: Culture / Team fit Ambitious / Hard working / Go getter / Coachable / Mentor Physical layer: fiber optic connections, contamination, cleaning Understand ESD best practices Comfortable with text based CLI Familiar with IP based networking A+/Network+ level of knowledge required Good understanding of OSI layer and network principles 2+ years of DC experience required 4+ years of IT related ex

Senior Staff, Software Quality Assurance Engineer

Stryker

Portage, Michigan, USA

Full-time

Work Flexibility: Hybrid Senior Staff, Software Quality Assurance Engineer Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2. Work Flexibility: Hybrid: Candidates must resi

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

San Juan, San Juan, Puerto Rico

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments. Test planning and strategy. creation and execution of test protocols, scripts and reports.

Network Engineer

Craig Technologies

Manassas, Virginia, USA

Full-time

Title: Network Engineer Location: Manassas, VA Clearance: Secret Clearance (or ability to obtain a clearance) Citizenship Requirement: ship Req #: 3902 Salary: $110,000 to $120,000 Summary: Craig Technologies has an opening for a Network Engineer supporting the work on the Submarine Command, Control, Communication Computers, Cyber-Defense & Intelligence contract supporting Systems Engineering & Intelligence. This work is located onsite in Manassas, Virginia and has a normal 9-10 work schedule.

Senior DeltaV Automation Engineer

Katalyst Healthcares and Lifesciences

Muskegon, Michigan, USA

Full-time

Job Description: Are you a DeltaV expert with hands-on experience developing automation code within the DeltaV platform? Do you thrive in a collaborative environment and enjoy mentoring junior engineers? If so, we want to hear from you! Responsibilities: Develop automation code within DeltaV (Control Modules, Equipment Modules, Phases, Recipes). Identify, troubleshoot, and resolve software errors within the DeltaV system. Conduct Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT),

Validation Support Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and

Senior Solution Architect - Austin TX / 1 Month Contract

Suncap Technology

Austin, Texas, USA

Contract

Senior Solution Architect Location: Austin, TX (full onsite) Hours: Monday-Friday: 8-5pm CST Duration: 1 month possible extension We are seeking a highly skilled and experienced professional to join our team as a Senior Solution Architect. As a key member of our team, you will be responsible for designing, implementing, and managing complex network infrastructure, including Dell Data Center switches, and ensuring seamless integration with other systems. ** Expected skillset - Required ** Residen

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Lexington, Massachusetts, USA

Full-time

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment. Execute approved protocols per company Good Documentation Practices (cG

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia

Compliance Lead

Adva IT Services, Inc..

Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc