OQ Jobs in Massachusetts

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Manufacturing Execution Systems (MES) Engineer

Tekaccel, Inc

•

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

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

Supplier Project Engineer

Kforce Technology Staffing

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Acton, Massachusetts, USA

Contract

RESPONSIBILITIES: Kforce has a client in Acton, MA that is seeking a Supplier Project Engineer with experience in FDA-regulated industries and strong skills in Minitab or JMP. This role is ideal for someone with a quality-focused mindset and a background in mechanical/automation or process/data analysis. Key Responsibilities: * Lead supplier capital qualifications from kickoff through production * Oversee validation/qualification protocols and reporting * Manage equipment procurement and instal
Posted 8 days ago | Updated 1 hour ago

Manager, IT/Senior Systems Analyst

Thermo Fisher Scientific

•

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

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

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

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

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

Sr. Equipment Engineer - 2nd Shift

Johnson & Johnson

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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

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

Validation Engineer, Sterile & Cleaning

Katalyst Healthcares and Lifesciences

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Bedford, Massachusetts, USA

Full-time

Responsibilities: We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently. This role involves performing revalidation tasks for equipment and working closely with cross-functional teams. Develop and execute
Posted 49 days ago | Updated 3 hours ago

Process Engineer

Katalyst Healthcares and Lifesciences

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Danvers, Massachusetts, USA

Full-time

Responsibilities: Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with pro
Posted 40 days ago | Updated 3 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Fall River, Massachusetts, USA

Full-time

Job Description: The Validation Engineer is responsible for developing DQ/IQ/OQ/PQ protocols and coordinating and performing equipment qualifications, ensuring that automated process equipment that mass produce medical device consumables and other products, are designed, developed or changed in compliance with specifications, requirements, safety and Company and regulatory guidelines. The Validation Engineer will work closely with Senior validation staff, maintenance, operations, and R&D teams t
Posted 49 days ago | Updated 3 hours 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

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
Posted 49 days ago | Updated 3 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Raynham, Massachusetts, USA

Full-time

Responsibilities: Ask candidates if they have validated equipment and what type of equipment they have validated. Mechanical/manufacturing experience. Writing and executing validation protocols. CSV is nice to have, but if the candidate has done that exclusively it will not work. Requirements: A minimum of a Bachelor's degree in Engineering is required. Minimum of 1-3 years' experience in medical device manufacturing, Bio/pharma is also good Develop and implement processes to support the
Posted 49 days ago | Updated 3 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 33 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

Principal Process Engineer - OPEX

Cardinal Health

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Chicopee, Massachusetts, USA

Full-time

Job Summary We are seeking a highly motivated and experienced Principal Process Engineer to join our team and lead continuous improvement initiatives within our medical device manufacturing facility. The ideal candidate will have a strong background in Lean Six Sigma methodologies and project management, with a proven track record of successfully implementing process improvements that enhance efficiency, productivity, and quality. The ideal candidate will have a breadth of experience gained from
Posted 10 days ago | Updated 3 hours ago

Principal Validation Engineer

Johnson & Johnson

•

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 23 days ago | Updated 3 hours ago