jobs in boston, ma, us

Boston, Massachusetts

•

16d ago

Job Description: Seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. Consultants will be responsible for hands-on execution of equipment commissioning and qualification activities, including reviewing and executing established qualification protocols, documenting test results, identifying and resolving execution issues, and supporting equipment readiness for manufacturing and engineering activities. T

Full-time

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

•

16d ago

Job Summary: leading organization is seeking an experienced Pharma IT Testing & Validation Delivery Lead to manage global testing and validation services across multiple Life Sciences programs. Roles & Responsibilities: Own end-to-end testing and validation delivery across multiple pharmaceutical IT projects. Lead onsite and offshore QA teams across the United States, United Kingdom, and India. Define testing strategy, governance, KPIs, delivery standards, and quality metrics. Oversee functional

Full-time

CSV Engineer

Boston, Massachusetts

•

16d ago

Job Description: Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require. Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, do

Full-time

Validation Engineer

Boston, Massachusetts

•

16d ago

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

Product Design Quality Engineer

Cambridge, Massachusetts

•

16d ago

Job Description: The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requirements, quality standards, and design control processes. This role partners with cross-functional teams to integrate quality into product development, risk management, validation, and manufacturing transfer activities. Responsibilities: Support Design Control activities throughout the product development lifecycle in

Full-time

Validation Engineer

Boxborough, Massachusetts

•

16d ago

Roles & Responsibilities : Test Stand & LabView experience along with some Manufacturing equipment validations (IQ/OQ /PQ) experience Test Engineer that can help qualify Automated Functional Testers. Would be responsible for writing all the documentation (requirement| trace matrix| protocols| reports using the Healthcare templates) and executing the validations. The code for the testers will be written by an internal resources with whom Candidate would work closely in order to complete the paper

Full-time

Senior RAVE Clinical Database Programmer

Remote or New Jersey

•

16d ago

Job Description: The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution. Key Responsibilities:

Full-time

Senior Rave Clinical Database Programmer

Remote or New York, New York

•

16d ago

Summary: The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution. Key Responsibilities: Serve as

Full-time

Senior SAS programmer (RWE)

Remote or New York, New York

•

16d ago

Summary: The senior programmer position will be responsible for manipulating large databases and generating reports to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS and SQL programming skills and the ability to implement complex logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience building patient cohorts and evaluating patien

Full-time

RWE Programmer (SAS)

Remote or New Jersey

•

16d ago

Job Summary: We are seeking an experienced Real World Evidence (RWE) Programmer with strong SAS, SQL, and R programming expertise to support observational research and healthcare data analytics initiatives for pharmaceutical and biotechnology clients. The ideal candidate will have hands-on experience working with large-scale healthcare claims and Electronic Health Record (EHR) databases, developing patient cohorts, and creating high-quality analysis datasets for real-world evidence studies. This

Full-time

CSV Engineer

Woburn, Massachusetts

•

16d ago

Job Summary: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer S

Full-time

Validations/ Verifications Engineer

Boston, Massachusetts

•

16d ago

Role Descriptions: Must Have Technical/Functional Skills Desirable Skills: Skills: EIS: Medical Device & Regulations ~EIS: New Product Development (NPD) Methodology and Management Experience Required: 4-6 5+ years of work experience in medical device industry Required: A bachelor's degree in Technical or Scientific discipline 5+ years of work experience in medical device industry Experience conducting Process Verifications / Validations Experience conducting Design and/or Process Failure M

Full-time

CQV Engineer

Remote or New Jersey

•

16d ago

Summary : This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manuf

Full-time

Senior Software Quality Assurance Engineer

Andover, Massachusetts

•

16d ago

Job Description As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and compliance across the product development lifecycle for Class II/ medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commerc

Full-time

Process Engineer

Raynham, Massachusetts

•

16d ago

Roles & Responsibilities Write and execute validation protocols and reports (IQ, OQ, PQ). Develop and implement manufacturing processes, specifications, operator instructions, process studies, and production readiness activities. Conduct investigations, root cause analysis, problem solving, and prepare reports/presentations. Update procedures, manufacturing specifications, bills, routes, and travelers for product/process changes in PLM systems. Work with equipment manufacturers and distributors

Full-time

MODA Systems Analyst

Remote or New Jersey

•

16d ago

Job Description: We are seeking a high-level Lab Systems Administrator for a fully remote position to execute administration, maintenance, and master data activities specifically for the MODA platform in support of the Massachusetts Biologics Operations (MBO) site. This role maintains system workflows, handles instrument interfaces, provides first-tier remote end-user support, and coordinates closely with Global system owners regarding system changes and communications. All requests, issues, and

Full-time

Medical Device V&V engineers

Remote or New Jersey

•

16d ago

Summary: We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Roles & Responsibilities: Design Controls: Lead efforts to deve

Full-time

CQV Engineer

Raynham, Massachusetts

•

16d ago

Job Description: We are looking for CQV Engineers / System Owners to take ownership of specific process and utility systems within either the Bulk (Drug Substance) or Fill Finish (Drug Product) areas on a large-scale greenfield project. This role focuses on system ownership across the full CQV lifecycle, from design review through to qualification and handover, ensuring all systems are delivered in line with GMP and project standards. Responsibilities: ct as System Owner for assigned equipment

Full-time

Senior Automation Engineer

Remote or New Jersey

•

16d ago

Roles & Responsibilities: Role requires a senior level automation engineer comfortable operating independently while supporting others. No CSV authorship responsibility: CSV activities are supported indirectly through automation execution and issue resolution. DeltaV DCS automation experience in pharmaceutical / biopharma manufacturing Strong troubleshooting and problem solving skills in live manufacturing environments, including commissioning, issue triage, and rapid resolution under GMP constr

Full-time

GxP System Engineer

Norwood, Massachusetts

•

16d ago

Job Summary: We are seeking an experienced GxP System Engineer with strong expertise in Hamilton Instrumentation, laboratory automation systems, and Computer System Validation (CSV) within a regulated pharmaceutical environment. The ideal candidate will support validation, compliance, qualification, and operational activities for critical laboratory systems while ensuring adherence to FDA regulations, GxP guidelines, and data integrity standards. The candidate should possess hands-on experience

Full-time

jobs in Boston, MA, USA