Process Validation Engineer Jobs

Refine Results
181 - 200 of 280 Jobs

Validation Engineer

Katalyst Healthcares and Lifesciences

Oceanside, California, USA

Full-time

Responsibilities: Lead or support cleaning, equipment, utilities, sterilization and/or autoclave qualification due to equipment modifications for tech transfers, Make-Assess-Release (MAR) or routine re-qualification activities. Ensure the timely completion of Cleaning Monitoring as well as validation team assignments. Any deviations, anomalies or schedule impacting items are to be reported to site management. This position provides trained technical resources for the development and executio

Validation Engineer

Katalyst Healthcares and Lifesciences

St. Louis, Missouri, USA

Full-time

Responsibilities: The Validation Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. Our Engineers are responsible for protocol writing and execution (field verification), and development of summary reports. Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines. Ability to work independently. Support onsite and offsite activities, such as: FATs, SATs, IOQ

Utilities Qualification(Validation) Engineer

Katalyst Healthcares and Lifesciences

Salt Lake City, Utah, USA

Full-time

Job Description: A pharmaceutical/biotech client in Utah is seeking a mid-to-senior level Utilities Qualification Engineer with 5+ years of experience in critical utilities validation and qualification. The candidate will support GMP manufacturing operations by qualifying and documenting systems like AHUs, purified water, compressed air, and legacy cleanroom systems. This is a fully onsite role and requires a self-driven individual with hands-on experience in IQ/OQ/PQ, EDMS tools (Glorya

Validation Engineer III

Katalyst Healthcares and Lifesciences

Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot

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

Validation Engineer

Katalyst Healthcares and Lifesciences

Nashville, Tennessee, USA

Full-time

Responsibilities: Ensure all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes: These confirm proper functionality and adherence to operational specifications. Validate manufacturing processes (e.g., blending, cutting, rolling, and packaging) to ensure consistent production of high-quality products. Conduct revalidation of equipment and processes when changes occur, such as: ssess risks related to equipment, processes, and production areas that could impact product qua

Validation Engineer

Katalyst Healthcares and Lifesciences

South Carolina, USA

Full-time

Responsibilities: Provide technical input to validation activities. Represent process validation during equipment installations. Support process validation Quality Systems. Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices. Participate in regulatory agency inspections for Process Validation. Serve as one of the main points of contact in communication to customers whose equipment and processes are being validate. Responsible

Site Validation Engineer

Katalyst Healthcares and Lifesciences

Holdrege, Nebraska, USA

Full-time

Responsibilities: Support the plant on assigned new and existing product initiatives with technical expertise and determine associated resource needs to accomplish project goals. Develop and maintain the Validation Master Plan and validation tracking schedule. Provide visibility related to all validation activities through tracking and reporting plant metrics. Support and influence change management within the plant: liaison between the core team, program managers, and Global quality. Conduct tr

Validation Engineer

Katalyst Healthcares and Lifesciences

Mossville, Illinois, USA

Full-time

Responsibilities: ssess and plan work to mitigate risk in NTI and NPI programs. Work with design leads to establish an initial first-pass test plan early in a program (pick list review to document leverage opportunity, VPD and potential test load). Participate in or Plan and Host Simulation and Test Collaboration Workshops (STCW) early in programs, pre-DFMEA to create high-level Validation Plan. Communicate progress in Gateway Reviews including System Readiness Summaries. Quality approval of FME

GXP Validation Engineer

Katalyst Healthcares and Lifesciences

Boca Raton, Florida, USA

Full-time

Responsibilities: 12 years' Experience in Validating systems and Experienced in GxP related applications. Perform review for GxP systems to ensure compliance with regulatory requirements as per the customer SOPs. Expertise on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology. Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test scr

Validation Engineer

Katalyst Healthcares and Lifesciences

Richmond, Virginia, USA

Full-time

Responsibilities: Ensure that all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm that they function correctly and meet operational specifications. Validate manufacturing processes to ensure they are capable of consistently producing products that meet quality standards. This includes processes like blending, cutting, rolling, and packaging. Regularly revali

Validation Engineer

Katalyst Healthcares and Lifesciences

Warsaw, Indiana, USA

Full-time

Responsibilities: Develops and Executes Cleaning Validation Strategies: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective cleaning processes for medical devices and equipment. Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends

Validation Engineer III

Katalyst Healthcares and Lifesciences

Plainsboro Township, New Jersey, USA

Full-time

Job Description: Qualified candidates must be experienced in one or more of the following areas of validation: Equipment Qualification Process Qualification The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with

PMU Silicon Validation Engineer

Apple, Inc.

No location provided

Full-time

Do you love building elegant solutions to highly complex challenges? Do you intrinsically see the importance in every detail? As part of our Silicon Technologies group, you'll help ensure Apple products and services can seamlessly and efficiently handle the tasks that make them beloved by millions! Joining this group means you'll be responsible for crafting and building the technology that fuels Apple's devices. Together, you and your team will enable our customers to do all the things they love

System Verification and Validation Engineer

Jacobs

Houston, Texas, USA

Full-time

Are you passionate about human space exploration, understanding the origins of the universe, and working with a passionate and diverse team to make a difference? If you are, we need you! We need your talent, teamwork, and energy to help us achieve great things that inspire people all over the globe. We need you to bring creative ideas and diverse backgrounds to help us envision, shape, and deliver systems that will enable the exploration of space while benefiting people here on Earth. We are exc

Wireless Systems Validation Engineer - NFC

Apple, Inc.

No location provided

Full-time

At Apple, we work every single day to craft products that enrich people's lives. Do you love working on challenges that no one has solved yet? Do you like changing the game? As a member of our dynamic group, you will have the unique and rewarding opportunity to shape upcoming products that will delight and inspire millions of Apple's customers every day. Apple's RF System Engineering team is looking for a passionate, self-motivated individual to work on integration of NFC technologies into Apple

Machine Learning Algorithm Validation Engineer

Apple, Inc.

No location provided

Full-time

Would you like to work on a dynamic team that is all about delivering an Apple-quality experience on some of the world's most creative products? We are the Product Systems Quality team, and we're looking for a highly motivated, energetic, and experienced Algorithm Validation Engineer with a passion for delivering robust, inclusive, and state-of-the-art Computer Vision and Machine Learning algorithms in Apple's next generation of products. You'll enjoy working on a team of QA engineers with diver

ADAS Validation engineer

MWIDM Inc.

Newark, California, USA

Contract

Your Role: Be responsible for test validation of hardware/software components related to ADAS/AD highway driving & safety functions such as Adaptive Cruise Control, Highway Assist, Lane Change Assist, Lane Departure Protection etc. Contribute in discussions to system architecture development & feature requirements, and develop related validation tests on component and vehicle level Assist with the management to the definition and build-up of our fleet of prototype and series production vehicles

Wireless RF OTA Connectivity Validation Engineer

Apple, Inc.

No location provided

Full-time

At Apple, we work every single day to craft products that enrich people's lives. Do you love working on challenges that no one has solved yet? Do you like changing the game? As a member of our dynamic group, you will have the unique and rewarding opportunity to shape upcoming products that will delight and inspire millions of Apple's customers every day. Apple's Wireless System Engineering team is looking for an engineer to work on radiated system characterization across different connectivity t

Validation Engineer

Katalyst Healthcares and Lifesciences

Piscataway, New Jersey, USA

Full-time

Position Overview: Looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Responsibilities: Generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, adhering to project timelines, ensure compliance with company and industry standards and participating in cross-functional teams. Required Skills: Experience with drafting and executing IQ / OQ / PQ. CAD proficiency to