entry level validation engineer Jobs

161 - 180 of 266 Jobs

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Springfield, Illinois, USA

Full-time

Job summary: Seeking a Facilities Validation Specialist who will be responsible for working across two state-of-the-art medical device facilities. They will have a long-term contract position with significant project ownership an opportunity to work with advanced cleanroom environments and warehouse facilities. Responsibilities: Lead facility commissioning activities across multiple sites. Conduct temperature and humidity mapping studies. Perform cleanroom validation for Class 6, 7, and 8 envi

Validation Engineer IIIJob Title - Validation Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Albany, Georgia, USA

Full-time

Responsibilities: Spearhead qualification protocols for next-generation manufacturing processes. Drive manufacturing investigations and implement innovative solutions. Design validation strategies for new product launches and technology transfers. Lead comprehensive IQ/OQ/PQ validation activities across multiple projects. Create robust standard operating procedures for manufacturing excellence. Ensure continuous process verification for robust manufacturing operations. Coordinate cross-fu

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Irvine, California, USA

Full-time

Responsibilities: NPD, NPI, Process & product development. Process and Equipment Validation. Process Characterization. good manufacturing practices and documentation. Process Improvement. Requirements: GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs. Knowledge in Experiment design and SPC. Management of statistical procedures. Strong creative, analytical and problem-solving skills. Comprehension of standard costs and

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Richmond, Virginia, USA

Full-time

Responsibilities: Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly. Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements. Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Collaborate with cross-functi

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Richmond, Virginia, USA

Full-time

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Huntington, Texas, USA

Full-time

Roles & Responsibilities: M.S. in Engineering or Biomedical Engineering 1+ year of professional experience in a Medical Device Manufacturing Environment Lead, execute, document & manage the validation activities (IQ/OQ/PQ) necessary to support the introduction or revision of automated and semi-automated production equipment and processes for Ophtalmic medical devices Design, develop, validate and implement manufacturing processes to build opthalmic medical devices for cataract and vitroreti

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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St. Louis, Missouri, USA

Full-time

Responsibilities: Provide technical support and routine process monitoring for commercial products manufactured at CMOs. Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team. Reviews manufacturing processes, deviations, and/or development and production data. Reviews manufacturing batch records, protocols, and control strategies. Provide technical support and data analysis for investigations and deviation resolution. Recommen

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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 EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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 EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Austin, Texas, USA

Full-time

Responsibilities: Author, review, and execute validation protocols (IQ, OQ, TMV, PQ) for process validation and re-validation activities in compliance with FDA/AAMI/ISO/EN guidelines/standards. Actively participate in all phases of process qualification. Evaluate projects, provide guidance and technical information, generate protocols, execute qualification activities, analyze data, and prepare reports. Lead all assigned qualification activities and make independent decisions related to thes

Site Validation EngineerJob Title - Site Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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 EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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 IIIJob Title - Validation Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Mid/Senior Level Validation Specialist/EngineerJob Title - Mid/Senior Level Validation Specialist/Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

GXP Validation EngineerJob Title - GXP Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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