Manufacturing Quality Engineering and Validation Consultant
Katalyst HealthCares & Life Sciences
Job-ID32769030Reference26-01329Remote50% Remote Job Description: The Quality Engineering and Validation Consultant is recognized as an expert internally in the principles and application of quality assurance and compliance. This position coordinates GMP activities in support of clinical and commercial Drug Product manufacture. This position reports to Associate Director GMP Quality - Cell & Gene. This is an onsite Monday through Friday position. Responsibilities: As part of the VCGT GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations and capital projects in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of validation, analytical laboratory, materials management, and facility/engineering groups. Provide QA support of change controls, validation protocols, risk assessments, GMP investigations and CAPAs. Responsible for identifying risks and communicating gaps for GMP process/systems Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications Review and approval of trending programs (equipment, facility, utilities, etc.) Support EM and Routine testing of facilities and utilities and control programs (Client/EMS, pest control, etc.) Requirements: Experience providing QA support and oversight of GMP manufacturing operations and capital projects Aseptic processing Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience with network-based applications such as Veeva, Nuvolo, Viewlinc Master's degree with 3-5 years of relevant work experience, or bachelor's degree in engineering, scientific or allied health field with minimum 8 years of relevant work experience, or relevant comparable background. Key Leadership Skills: Collaboration / Teamwork / Conflict Management Results Driver Key Knowledge/ Skills and Competencies The ability to thrive in a high throughput environment Foster cross-departmental collaboration within project teams to ensure alignment and timely resolution of issues. Ability to independently collaborate on cross-functional teams and represent the Quality unit Ability to communicate effectively across all organizational levels Critical Thinking / Problem Solving Ability to evaluate quality matters and make decisions utilizing risk-based approach Attention to detail
- InterSystems Corporation is seeking a technically skilled AI validation specialist to join a cross‑functional agile team focused on product quality in healthcare IT. You will develop AI test strategies, validate non‑deterministic AI applications, and ensure performance...Suggested
- InterSystems is seeking a Technical Specialist to enhance quality in healthcare technology by developing AI validation methodologies. Your role involves collaborating with Agile teams to ensure high-caliber testing while utilizing cutting-edge tools. Ideal candidates will...Suggested
- ...Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring... ...with manufacturing, engineering, and supplier teams to resolve... ...process monitoring and support validation activities (IQ/OQ/PQ as required...Suggested
$86.7k - $170.9k
Position Summary Regulatory & Financial Risk - Consultant - Model Validation Our Deloitte Regulatory, Risk & Forensic team helps client leaders... ...and Agentic AI behaviors and controls, including response quality evaluation, hallucination and grounding checks for...Suggested$93.6k - $154.5k
...The Life Sciences Risk Consulting Services team supports organizations... ...environments where validated systems, reliable data,... ...activities across quality, laboratory, manufacturing, and enterprise platforms... ...Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing...SuggestedFull timeWork experience placementSummer holidayFlexible hours$65k - $90k
...Job Title: Manufacturing Quality Engineer Location: Watertown, MA Job Type: Full-Time | On-site Pay Range: $65,000 - $90,000 annually Benefits: Competitive Bonus Program Well-Funded Health Insurance Plan Dental Insurance...Permanent employmentFull timeWork at officeLocal area$60 - $65 per hour
A leading life sciences consulting firm is seeking a Validation & Quality Assurance Consultant to provide QA support for GMP operations in Boston. This role... ...or a Bachelor's degree and extensive background in engineering or sciences. Salary is competitive, with an hourly...Hourly pay$60 - $65 per hour
Overview Role: Validation & Quality Assurance Consultant (GMP) Location: Boston, MA (Onsite - Monday to Friday... ...Role We are seeking a Quality Engineering and Validation Consultant to support... ...QA oversight and support for GMP manufacturing operations and capital projects....Hourly payContract workMonday to Friday$90k - $115k
...has an exciting opportunity for an IT Quality Engineer to join our Boston-based Information Technology... ...and work with onsite and offshore consulting partners in executing our automation... ...User Acceptance Testing to facilitate validation and troubleshoot user feedback....Temporary workWork experience placementFlexible hours- ...054Reference26-00746 Job Summary: The Quality Engineer will support the Quality Information Systems... ...computerized system projects across Manufacturing, Laboratory, and Enterprise platforms.... ...compliance with data integrity, validation, regulatory, and quality requirements...
- ...device industry· Experience conducting Process Verifications / Validations· Experience conducting Design and/or Process Failure Modes... ...technical and/or project leadership experience· Design Quality Engineering experience· Design Control experiencePreferred:· An advanced...Work experience placement
- ...Responsibilities: We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. Candidates must have... ...scrutiny. Cross-functional collaboration with Quality, Manufacturing Engineering, R&D, QC,...
$82.3k - $220k
...challenges with a promise of delivering successful and usable solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our multidisciplinary teams of engineers and scientists work in a collaborative...Full timeLocal area- ...integrated architecture, engineering, construction, system integration, and consulting firm committed to... ...only firm born from a manufacturing technology company to... ...:Job SummaryThe Validation Engineer III will serve... ...MappingQuality Management (Quality Risk Assessments;...Full timeFor contractorsWork at office
$107.1k - $160.7k
...practice. Our architects, engineers, interior designers, consultants, sustainability... ...Together, we are enhancing the quality of life globally through... .... The Commissioning and Validation role provides crucial services... ...where drug products are manufactured, stored in GMP...Full timeTemporary workPart timeCasual workWork at officeLocal areaImmediate startFlexible hours- ...Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus... ...- Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant... ...- Essential experience in a GMP (Good Manufacturing Practice) environment- Outstanding oral...Full timeFor contractorsWorldwide
$150k - $250k
...OverviewWe are seeking a highly skilled Senior ASIC Verification Engineer to join our dynamic team. This role is pivotal in ensuring the... ...design intent and provide feedbackPerform RTL verification and validate key components including memory subsystems and interconnect...- ...ensuring vendors meet all site requirements. Schedule/plan/execute validation activities and preventive maintenance of laboratory equipment... ...: Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of Industry relevant experience Or Master...Work at officeImmediate startShift work
- ...Summary: We are seeking an experienced Validation Engineer to support system-level Verification &... ...with FDA, ISO 13485, and internal quality system requirements. Experience with infusion... ...including R&D, Quality, Regulatory, Manufacturing, and Systems Engineering. Support...
- ...Quality EngineerWe are seeking a Quality Engineer to join our team and support quality management initiatives across manufacturing and operational processes. This role will be responsible for driving... ...and preventive actions, validation activities, and quality systems...Work at office
$146k - $194k
...technology to the military in months, not years.ABOUT THE TEAM:Our Quality Engineering team is a dedicated group of professionals committed to... ...and outcomes.ABOUT THE JOB:We are seeking a Senior Manufacturing Quality Engineer to join our growing team, currently based...Full timeWork experience placementImmediate startRelocation- ...Computer System Validation SpecialistThis role will focus on the Computer... ...of Business, IT, and Quality personnel. Experience with current... ....Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry... ...biotechnology, or regulated manufacturing environments. 5+ years of...
$129k - $171k
...refreshed maritime vehicle and flexible manufacturing architecture that scales from “large”... ...JOB We are seeking a Manufacturing Test Engineer to join Anduril, working in a cutting-edge... ...to ensure the highest levels quality are achieved as we continue drive scalability...Full timeWork experience placementImmediate startFlexible hours$90k - $165k
...Sr. Verification Engineer A Verification Engineer is a technical position responsible for testing and verification of software as a... ...documentation of verification tests within schedule constraints, meeting quality standards and goals. Role Responsibilities: • Estimate,...- ...Service Reports To: Regional Service Manager Payroll Type: Salary FLSA Status: Non-Exempt Job Summary: As a System Validation Specialist, you have hands on experience with installing, troubleshooting, repairing, calibrating, and inspecting monitoring...Local areaRemote work
$72.8k - $80.1k
...Experience- Bachelor's degree in a science or engineering field (or equivalent experience)- 0 - 4... ...automationPharmaceutical manufacturing processesCritical CompetenciesInfluence... ...anticipates customer needsDelivers high-quality solutions and serviceProactively maintains...Worldwide- ...A technology startup in Boston is seeking a Senior ASIC Verification Engineer to lead verification efforts for silicon, IP, and subsystems. The ideal candidate has over 5 years of experience in ASIC/SOC verification and excels in technical leadership and stakeholder management...Visa sponsorshipRelocation package
$102.1k - $111.7k
...Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus... ...'s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant... ...industryEssential experience in a GMP (Good Manufacturing Practice) environmentOutstanding oral...For contractorsWorldwide$140k - $165k
...cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid... ...to prevent heart attacks and strokes!As a Senior Clinical Validation Engineer, you’ll be at the forefront of advancing our AI-powered...Work at officeLocal areaRemote work- A leading entertainment company in Boston is seeking a Senior Quality Engineer to enhance the quality of their digital products. This role involves planning and executing manual and automated tests, managing CI/CD processes, and collaborating with development and product...Flexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Manufacturing Quality Engineering and Validation Consultant. Be the first to apply!
- advanced manufacturing engineer Boston, MA
- additive manufacturing engineer Boston, MA
- manufacturing technology engineer Boston, MA
- senior manufacturing engineer Boston, MA
- digital manufacturing engineer Boston, MA
- manufacturing engineering tech Boston, MA
- manufacturing engineer specialist Boston, MA
- manufacturing engineer Boston, MA
- advanced quality engineer Boston, MA
- quality systems engineer Boston, MA

