OQ Jobs in New York

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Process Engineering Manager

Thermo Fisher Scientific

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Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Various outside weather conditions, Warehouse Job Description Job Overview: At Thermo Fisher Scientific Inc., we offer an exceptional opportunity for a bold Process Engineering Manager to lead our divisional LCD Process improvement program. You will play
Posted 23 days ago | Updated 3 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 36 days ago | Updated 3 hours ago

CQV Engineer

Katalyst Healthcares and Lifesciences

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Brooklyn, New York, USA

Full-time

Responsibilities: Develop commissioning and qualification protocols for HVAC, purified water systems, clean utilities, and other critical utilities according to regulatory requirements (GMP, FDA, etc.). Execute commissioning and qualification activities for utilities systems, ensuring adherence to project schedules and quality standards. Conduct risk assessments, impact assessments, and gap analyses related to utilities systems. Coordinate with cross-functional teams including engineering, q
Posted 49 days ago | Updated 3 hours ago

Validations Engineer

Katalyst Healthcares and Lifesciences

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Piscataway, New Jersey, USA

Full-time

Roles & Responsibilities: We're looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Experience with drafting and executing IQ/OQ/PQ. CAD proficiency to support the update of various P&IDs. Problem solving and troubleshooting skills to be able to identify and resolve issues through the validations. Good Communication and documentation Skills. Knowledge with USP water. Major job functions include generation of qualification / va
Posted 23 days ago | Updated 3 hours ago

Validations Engineer

Katalyst Healthcares and Lifesciences

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Piscataway, New Jersey, USA

Full-time

Job Description: We're looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Roles & Responsibilities: Bachelor's degree. Experience with drafting and executing IQ/OQ/PQ. CAD proficiency to support the update of various P&IDs. Problem solving and troubleshooting skills to be able to identify and resolve issues through the validations. Good Communication and documentation Skills. Knowledge with USP water. Year of experience: 5&pl
Posted 25 days ago | Updated 3 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 49 days ago | Updated 3 hours ago

Automation Control Engineer

Katalyst Healthcares and Lifesciences

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South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa
Posted 49 days ago | Updated 3 hours ago

LIMS Master Data Specialist

Katalyst Healthcares and Lifesciences

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Summit, New Jersey, USA

Full-time

Position Summary: Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement. Responsibilities: Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers. Provide electronic systems operational support and troubleshooting to end use
Posted 49 days ago | Updated 3 hours ago

Supplier Project Engineer

Gardner Resources Consulting, LLC

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Remote

Contract

Education and Experience: 3 years of relevant experienceBS Engineering Degree (Plastics, Mechanical, Manufacturing/Industrial) or related fieldPreferred Skills and Competencies: Ability to manage Supply Chain projects concept to production, including the authoring and oversight of IQ/OQ/PQ protocols for component manufacturing processes and secondary Job Description Summary operations: Strong written and verbal communication skills Possess strong analytical and problem-solving skills Familiari
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Posted 6 days 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 28 days ago | Updated moments ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end
Posted 49 days ago | Updated 3 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 49 days ago | Updated 3 hours ago

DeltaV Automation Engineer - Pharmaceuticals

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is hiring a DeltaV Automation Engineer for a growing BioPharma company located in Holly Springs, NC. The DeltaV Automation Engineer will be responsible for designing, developing, and maintaining automation systems for pharmaceutical manufacturing processes. This role requires expertise in Emerson DeltaV DCS (Distributed Control System), with a focus on process optimization, validation, and compliance with industry regulations. The DeltaV Automation Engineer can work remote, but w
Posted 16 days ago | Updated 15 days ago

Trackwise Digital Architect

VeridianTech

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Texas, USA

Full-time

Trackwise Digital Architect Remote Requirement Experience with designing and implementing IT systems. Experience with understanding specifications, evaluate current application, gather requirements, and work closely with stakeholders to deliver the right solution Experience working and implementing systems using TrackWise Digital platform. Hands on experience in TrackWise Digital Application setup: Permission Sets, Configuring Platform Custom Settings, Configuring Remote Site Settings, E-s
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Posted 60+ days ago | Updated 4 hours ago

Manufacturing Execution Systems (MES) Engineer

Tekaccel, Inc

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Remote

Contract, Third Party

About the Role: We are seeking a skilled MES Engineer to join our team, where you ll work closely with the Global IT organization and site stakeholders to understand and address critical business needs in Pharmaceutical/Biotech manufacturing environments. You ll play a key role in designing, implementing, validating, and supporting cutting-edge MES (Manufacturing Execution System) solutions, ensuring systems remain compliant and deliver meaningful value to operations. Key Responsibilities: Colla
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Posted 1 day ago | Updated 1 day 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 49 days ago | Updated 3 hours ago

Manager, IT/Senior Systems Analyst

Thermo Fisher Scientific

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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: Manager, IT/Senior Systems Analyst HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Support Thermo Fisher's integration of Tracelink (Track and Trace Solution) and Thermo Fisher's downstream partners to ensure Thermo Fisher is compliant with Serialization and Track and Trace requirements and detailing the technical
Posted 4 days ago | Updated 3 hours ago

Senior 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 51 days ago | Updated 3 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 49 days ago | Updated 3 hours ago

Supplier Engineer II

Johnson & Johnson

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Remote or Danvers, Massachusetts, 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 51 days ago | Updated 3 hours ago