Process Validation Engineer Jobs in Pennsylvania

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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
Posted 60+ days ago | Updated 7 hours ago

Computer Systems Validation Engineer

Katalyst Healthcares and Lifesciences

•

Bethlehem, Pennsylvania, USA

Full-time

Job Description: We're seeking an experienced Computer Systems Validation (CSV) professional to join our team and lead end-to-end validation activities supporting laboratory system upgrades and data integrity initiatives. This role is ideal for someone with a strong background in regulated environments and hands-on experience with modern lab software and instrumentation. This is a short-term contract assignment running through September and requires individuals to work onsite. Responsibilities
Posted 3 days ago | Updated 7 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 19 days ago | Updated 7 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

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. V
Posted 60+ days ago | Updated 7 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the
Posted 60+ days ago | Updated 7 hours ago

Electrical Validation Engineer

Steck Systems

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Remote

Contract, Third Party

Job: Senior Electrical/Systems Test Engineer What the job involves We are seeking an Electrical/Systems Test Engineer to join our team. In this role, you will play a critical part in the testing and validation of our hardware systems. You will work on Electrical/system testing, validation, and hardware debugging of electrical components and systems involving edge processors, cameras and Linux environment. Responsibilities You will be responsible for system-level testing & debugging, and hardware
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Posted 4 days ago | Updated 6 hours ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 9 days ago | Updated 7 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 29 days ago | Updated 7 hours ago

Mid/Senior Level Validation Specialist/Engineer

Katalyst Healthcares and Lifesciences

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Pennsylvania, USA

Full-time

Roles & Responsibilities: Minimum of Four (4) years of experience with commissioning and qualification including using ISPE C&Q guidelines. Knowledge of Kneat e validation software preferred. Prior experience with analytical instrumentation qualification and controlled temperature unit qualification is required. Strong technical writing skills, verbal and written communication skills. Strong interpersonal skills (requires interaction with client employees). Responsible for the development an
Posted 60+ days ago | Updated 7 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Philadelphia, Pennsylvania, USA

Full-time

Job Summary The Validation Engineer is responsible for executing equipment and system validation activities within a regulated biopharmaceutical environment. This role involves implementing validation protocols, documenting results, and ensuring compliance with regulatory requirements. The position is based in West Philadelphia, Pennsylvania with a hybrid work arrangement. Responsibilities: Proficiency in Kaye AVS validation software. Experience with Valpro validation management systems. Compet
Posted 60+ days ago | Updated 7 hours ago

Mid/Senior Level Validation Specialist/Engineer

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
Posted 60+ days ago | Updated 7 hours ago

SAP Data Migration - IV&V (Independent Verification and Validation)

Taras Technology LLC

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Harrisburg, Pennsylvania, USA

Contract, Third Party

Minimum Experience Minimum 10+ Years experience in SAP Data Migration Must have solid experience in Independent Verification and Validation (IV&V). Excellent writing skills and ability to make presentations to various audiences. Highly preferred experience in Road Tolling. Taras Technology, LLC is an EEO/AA Employer: women, minorities, the disabled and veterans are encouraged to apply
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Posted 1 day ago

GE EMS Expert / EMS Validation Specialist and RT SCADA

PeakIT

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Remote

Contract

Job Title: RT SCADA to EMS GE EMS Expert / EMS Validation Specialist Location: Remote Job Type: 12 Months Contract Role Overview: We are seeking a highly skilled RT SCADA to EMS Expert with deep experience in GE EMS platforms, real-time data integration, and EMS validation processes. This role will be instrumental in supporting the deployment, integration, and validation of SCADA/EMS systems to ensure secure, stable, and efficient grid operations. Ideal candidates will have a strong background i
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Posted 11 days ago

Validation Lead

TechDigital Corporation

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King of Prussia, Pennsylvania, USA

Third Party, Contract

Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterf
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Posted 27 days ago

Validation Lead, SAP S4 HANA

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati
Posted 60+ days ago | Updated 7 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 7 hours ago

Sr. Analyst, IT Validation Services

Russell, Tobin & Associates

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Remote or Stamford, Connecticut, USA

Contract

Job Title: Sr. Analyst, IT Validation Services Location: Remote Duration: 12 Months Pay Range: $30/hr-$35/hr on W2 (DOE) Primary Responsibilities Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls: Validation Plans/Summary Reports Risk Assessments User Requirements Specifications Test Plans Test Scripts: IQ, OQ or PQ Assess and implement the most effective validation strategy for each activity. Oversee test execution for c
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Posted 55 days ago | Updated 2 hours ago

EMS Validation Engineering Lead

Schneider Electric

•

Horsham, Pennsylvania, USA

Full-time

For this U.S. based position, the expected compensation range is $96,000 - $144,000 per year, which includes base pay and short-term incentive. The compensation range for this full-time position applies to candidates located within the United States. Our salary ranges are determined by reviewing roles of similar responsibility and level. Within the salary range, individual pay is determined by several factors including performance, knowledge, job-related skills, experience, and relevant educatio
Posted 16 days ago | Updated 7 hours ago

Technical Lead - Validation, Tools, and Acceleration (VTA)

General Motors

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Remote

Full-time

Job Description Remote: This role is based remotely but if you live within a 50-mile radius of [Atlanta, Austin, Detroit, Warren, Milford or Mountain View ], you are expected to report to that location three times a week, at minimum. Role Overview: As a Technical Lead within the Validation, Tools, Acceleration (VTA) team under the Simulation, Evaluation, and Data organization, you will be a senior individual contributor building and optimizing the infrastructure and required technology for all
Posted 47 days ago | Updated 4 hours ago

REMOTE - RT SCADA to EMS ? GE EMS Expert / EMS Validation Specialist

Metasys Technologies

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Remote

Contract

RT SCADA to EMS - GE EMS Expert / EMS Validation Specialist Remote 12+Month ContractThis role will support the deployment, integration, and validation of SCADA/EMS systems to ensure secure, stable, and efficient grid operations. Candidates must have deep experience with GE EMS platforms, real-time data integration, and EMS validation processes. Responsibilities Support deployment, integration, and validation of SCADA/EMS systems Configure and validate real-time data exchange using protocols (DNP