pharma validation engineer Jobs

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Validation Engineer

Katalyst Healthcares and Lifesciences

Tarrytown, New York, USA

Full-time

Responsibilities: Validation & Qualification: Perform and support IQ/OQ for new fill-finish equipment and filling lines. Ensure that all equipment is installed and operating according to design specifications and regulatory standards. Commissioning Support: Assist with the commissioning of new equipment, ensuring all systems and equipment function properly before starting the qualification process. Documentation: Prepare, review, and maintain detailed validation protocols, reports, and document

Validation Engineer

Katalyst Healthcares and Lifesciences

San Jose, California, USA

Full-time

Responsibilities: Process and equipment qualification (IQ/OQ/PQ). Development of test methods for Design V&V, Process Validation, and Production. Validation of test methods. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work. Authoring/releasing of new test methods and editing/redlining of old test methods. Experience working in a regulated and/or medical device environment. To define equipment requirements. To draft equipment specification

Process Validation Engineer

Katalyst Healthcares and Lifesciences

Swiftwater, Pennsylvania, USA

Full-time

Roles & Responsibilities: Bachelor's degree in science or engineering (MS accepted, PhD is overqualified). Minimum 2+ years in Process Validation within the biotech/pharma industry. Writing and executing process validation documents. Strong Process Performance Qualification (PPQ) experience. Hands-on experience collecting process samples. Must have on-the-floor manufacturing experience. Familiarity with GMP best practices. Proficient in MS Office (Word, Excel, PowerPoint). Strong w

Validation Engineer II

Katalyst Healthcares and Lifesciences

Athens, Georgia, USA

Full-time

Responsibilities: Perform Smoke studies and assist in semiannual Media fill qualifications as a SME Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouse areas. Has worked with Ellabs data loggers and software. Write and execute protocols and complete final reports. Understanding of cleaning validation concepts and principles. Understands pharma grade utilities (water HVAC, gases). Requirements: Support Maintenance, Engineering

Validation Engineer

Katalyst Healthcares and Lifesciences

Raynham, Massachusetts, USA

Full-time

Responsibilities and Requirements: Packaging, Cleanroom, Equipment validation, Process Validation, IQ, OQ, PQ, Product transfer and Manufacturing transfer. 4-6 years of experience is required. Validation Engineer Manufacturing Engineer with Packaging, Cleanroom, Equipment machine validation experience good communication skill- good experience in validations (IQ/OQ/PQ). 5+ years of Working Experience machine shop environment. Good communication skills, Machining background, has worked in a

Process Validation Engineer

Katalyst Healthcares and Lifesciences

East Windsor, New Jersey, USA

Full-time

Responsibilities: Previous experience as a validation engineer in an aseptic pharmaceutical fill/finish environment. Prior experience executing validation protocols on a pharmaceutical fill/finish line. Specific line components include. Lyophilizers. Depyrogenation tunnels. Autocalves. Previous experience with the project management requirements of validation project in a GMP environment. Requirements: Managing validation schedule. Communication of delays and changes to timelines. Coor

Lab Equipment Validation Engineer

Katalyst Healthcares and Lifesciences

Philadelphia, Pennsylvania, USA

Full-time

Responsibilities: Our client is looking for a lab equipment validation engineer to come on-site for a 6 months project. This work will be fully on-site in PA. They are moving buildings, so all of the Laboratory equipment will be decommissioned and then put in the new building. They need this Consultant to come in and requalify, revalidate, and commission the Laboratory Equipment. They will also be getting some new Laboratory Equipment in as well - HPLC, Cell Counters.Requirements: This Consultan

Validation Engineer Senior

ACL Digital

Thousand Oaks, California, USA

Full-time

Responsibilities: Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines. Work with project teams to develop the commissioning and qualification strategy and document in qualification plans. 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 discrepancie

FMS Verification & Validation Engineer- Aerospace Industry

DBSI Services

Remote or Cedar Rapids, Iowa, USA

Full-time

Benefits: 401(k) 401(k) matching Relocation bonus Position: FMS Verification & Validation Engineer Location: Remote About the Role: We are seeking a skilled Verification Engineer with expertise in Flight Management Systems (FMS) The ideal candidate will have experience in verification and validation (V&V) processes for avionics systems, with a strong background in display, navigation, and application systems within FMS Skill Matrix: Yrs. In Flight Management Systems Yrs. In verification and v

Validation Engineer

ACL Digital

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 equipme

Sr. Process Validation Engineer

Katalyst Healthcares and Lifesciences

Grand Rapids, Michigan, USA

Full-time

Roles & Responsibilities: Minimum 7 years of CQV experience in a parenteral fill/finish environment. Lead process validation projects of broad scope. Responsible for project deliverables such as VMPs, pFMEAs, PPQ protocols and reports, change control assessments, technical transfer assessments, as well as other client deliverables as required. Provide technical support to Manufacturing - troubleshooting and resolving process related issues. Participate in investigations and provide documentation

Process Validation Engineer

Katalyst Healthcares and Lifesciences

Danvers, Massachusetts, USA

Full-time

Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout, Modeling, and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / Updating MPIs. Supplier Development and Component Engineering. Manufacturing Engineering Support / Engineering Documentation. Update work instructions to match the practice on the floor to what's in the p

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

Mid/Senior Level Validation Specialist/Engineer

Katalyst Healthcares and Lifesciences

Marietta, Pennsylvania, USA

Full-time

Roles & Responsibilities: Prior experience with Aseptic Fill Finish Equipment or Lyophilizes is required. Strong technical writing skills, verbal, and written communication skills. Strong interpersonal skills (require interaction with client employees). Responsible for the development and execution of validation life cycle deliverables associated with this project. Minimum of Five (5) years of experience with commissioning and qualification including using ISPE C&Q guidelines. Knowledge of

FPGA/ASIC Validation, Staff Engineer

Synopsys, Inc.

Sunnyvale, California, USA

Full-time

Descriptions & Requirements Job Description and Requirements We Are: At Synopsys, we drive the innovations that shape the way we live and connect. Our technology is central to the Era of Pervasive Intelligence, from self-driving cars to learning machines. We lead in chip design, verification, and IP integration, empowering the creation of high-performance silicon chips and software content. Join us to transform the future through continuous technological innovation. You Are: You are a highly

Post Silicon Validation and Application Engineer

Cisco Systems, Inc.

San Jose, California, USA

Full-time

The application window is expected to close on 6/3/25. This role will work onsite out of our San Jose, CA office. The Common Hardware Group (CHG) delivers the silicon, optics, and hardware platforms for Cisco's core Switching, Routing, and Wireless products. We design the networking hardware for Enterprises and Service Providers of various sizes, the Public Sector, and Non-Profit Organizations across the world. Cisco Silicon One (#CiscoSiliconOne) is the only unifying silicon architecture in

Validation Engineer

ACL Digital

California, USA

Full-time

Job Title: Validation Engineer Location: La Verne, CA Duration: 12+ Months Description: Independent engineer who have in depth knowledge about validation lifecycle management and be able to write VMP, protocols and corresponding summary reports ble to execute test protocols independently and resolve deviation and collaborate with engineering team, business process owner and QA to make changes if necessary. Able to investigate failure and write deviation and change control records. Experienc

Senior System Power Validation and Applications Engineer

NVIDIA Corporation

Santa Clara, California, USA

Full-time

Our technology has no boundaries. Nvidia is building the world's most groundbreaking and brand-new compute platforms for the world to use. It's because of our work that scientists, researchers, and engineers can advance their ideas. At its core, our visual computing technology not only enables an amazing computing experience, but it is also energy efficient! We pioneered a supercharged form of computing loved by the most fast-paced computer users in the world - scientists, designers, artists, an

Equipment Validation Engineer

Katalyst Healthcares and Lifesciences

Raynham, Massachusetts, USA

Full-time

Responsibilities and Requirements: Validation Engineer Manufacturing Engineer with Packaging, Cleanroom, Equipment machine validation experience. Good experience in validations (IQ/OQ/PQ)5+ years of Working Experience machine shop environment. Good communication skills, Machining background. Has worked in a Packaging, Cleanroom, Equipment machine shop environment (within med device or aerospace preferred). Product / Manufacturing Transfer activities.

Computer System Validation

Smart Bot Systems

Raritan, New Jersey, USA

Contract, Third Party

Job Details : Computer System Validation Mandatory Skills - Computer System Validation, GxP Regulations, Validating GxP systems Job Details: 7-10 years' experience in Computer System Validation ERP/WMS, R&D systems A senior consultant with expert knowledge of GxP and Computer System Validation. Expertise in authoring and reviewing all CSV validation deliverables. Proficient in Compliance Plan, User Stories, Testing, Traceability Matrix and SDLC lifecycle activities. Knowledge in utilizing SDLC