Validation Specialist

Katalyst HealthCares & Life Sciences

Job-ID Reference Job summary:We are seeking an experienced Validation Specialist to support validation activities in a GMP-regulated environment.Roles and Responsibilities:10 years of experience in Validation within Pharma, Biotech, or Life SciencesHands-on experience with IQ, OQ, and PQExperience with equipment, facility, utility, or process validationStrong knowledge of GMP, GxP, and FDA regulationsExperience developing and executing validation protocols and reportsExperience with deviations, CAPA, change controls, and risk assessmentsExperience supporting FAT/SAT, commissioning, and qualification activitiesStrong technical writing and documentation skillsAbility to work with Engineering, Quality, Manufacturing, and Validation teams

Apply

Vacancy posted 4 days ago

Similar jobs that could be interesting for youBased on the Validation Specialist in Boston, MA vacancy

Validation Engineering
...Computer System Validation SpecialistThis role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area. This role will be supporting validation leads to help...
Suggested
Katalyst HealthCares & Life Sciences
Cambridge, MA
3 days ago
Validation Engineering
**Role Number:** 200606302-6205 **Summary** In this highly visible role, you will perform lab characterization and validation of various analog & mixed signal embedded circuits; and collaborate with multi-functional teams to launch the world's most premiere mobile SoC'...
Suggested
Apple
Watertown, MA
3 days ago
Validation Engineering
$90k - $120k
...report quality-related issues. Train customers on instrument operation and best practices. Assist with customer site readiness and validation efforts.Validation, Field Service Engineer, troubleshooting, repair, analytical skill, instrumentation calibration,...
Suggested
Permanent employment
Actalent
Woburn, MA
1 day ago
Validation Engineer III
...,000 team members united by a common belief: to use the power of business to build a better world.Job Description:Job SummaryThe Validation Engineer III will serve as a key member of the validation team, providing expert-level support to ensure facility equipment, utilities...
Suggested
Full time
For contractors
Work at office
Barry-Wehmiller
Boston, MA
3 days ago
Validation Engineering
...Validation EngineerBoston, Massachusetts, United StatesA career here is life-enhancing.At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough...
Suggested
Work at office
Remote work
Work visa
Flexible hours
Syner-G BioPharma Group
Boston, MA
3 days ago
Validation Engineer
...Benchtop Lab Systems Validation SpecialistBenchtop instrument validation is must. QC computerized Lab Benchtop Systems (HIAC, FTIR, TOC, Bioanlyzers, Sequencers, etc.) and Enterprise Instrumentation Systems including optimizations, compliance enhancements, support, maintenance...
Anveta
Cambridge, MA
3 days ago
Validation Engineer
...Validation EngineerWe are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments.Candidates must have strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy...
Katalyst HealthCares & Life Sciences
Cambridge, MA
3 days ago
Validation Engineering Tech
...graphics, video encoding, video processing, file systems, CPUs and caching, kernel programming, embedded systems) to develop graphics validation software and integrate it into system level test environment. **Description** You will be writing shaders that stress the GPU and...
Apple
Watertown, MA
2 days ago
Validation Engineering
...Validation EngineerLocation: Boston/Cambridge, MAIndustry: Cell & Gene Therapy / Life SciencesJob Description: We are seeking a Validation Engineer to support qualification, requalification, and validation activities within a GMP-regulated Cell and Gene Therapy facility...
Theoris
Boston, MA
2 days ago
Validation Engineering Tech
...Validation EngineerLandmark Bio is dedicated to translating cutting-edge research into life-changing therapies. Headquartered in Watertown, Massachusetts, the company was founded by leading academic institutions, research hospitals, and industry partners to accelerate...
For contractors
Remote work
Work from home
Home office
Landmark Bio
Watertown, MA
3 days ago
Validation Engineering
...instrumentation. • Coordinate all services provided by vendors, ensuring vendors meet all site requirements. Schedule/plan/execute validation activities and preventive maintenance of laboratory equipment. Skills:• Demonstrated scientific technical writing ability. •...
Work at office
Immediate start
Shift work
Artech
Boston, MA
2 days ago
Senior Commissioning/Validation Specialist
$107.1k - $160.7k
..., engineers, interior designers, consultants, sustainability specialists, and technologists are passionate about the power of design.... ...that support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and...
Full time
Temporary work
Part time
Casual work
Work at office
Local area
Immediate start
Flexible hours
Stantec
Boston, MA
3 days ago
Staff Hardware Test Engineer (Manufacturing)
$180k - $215k
..., raise engineering standards, and mentor engineers across the team. RESPONSIBILITIES: Lead the architecture, development, validation, and deployment of automated test equipment (ATE), electrical test fixtures, and control systems for engineering validation, NPI,...
Full time
Work at office
Relocation
Whoop
Boston, MA
1 day ago
CSV Consultant: Bioinformatics & GMP Validation Specialist
Creative Solutions Services, LLC is seeking an experienced Computer System Validation (CSV) Consultant to support a biotech client in validating bioinformatics software and data analysis platforms within a GMP-regulated environment in Norwood, MA. Responsibilities include...
Creative Solutions Services, LLC
Norwood, MA
6 days ago
Senior Clinical Validation Engineer
$140k - $165k
...costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes! As a Senior Clinical Validation Engineer, you’ll be at the forefront of advancing our AI-powered cardiovascular imaging software. In this role, you’ll lead...
Work at office
Local area
Remote work
Flexible hours
Elucid
Boston, MA
19 days ago
Validation Engineering
...Senior Validation EngineerClient is seeking a Senior Validation Engineer to support digital initiatives within the Bioanalytical and Molecular Assays department of CASL. This role will report directly to the Senior Manager of Operations and will be responsible for delivery...
Software Technology Inc
Norwood, MA
3 days ago
Validation Engineering
$165.8k - $292.4k
...Silicon Validation Engineer In this highly visible role, you will perform lab characterization and validation of various analog & mixed signal embedded circuits; and collaborate with multi-functional teams to launch the world's most premiere mobile SoC's. At Apple,...
Relocation
Apple
Waltham, MA
3 days ago
Senior Engineering, Test Engineering
$118.6k - $174k
...What You’ll Do As a Senior RF Test Engineer, you will be a key technical leader responsible for RF product development and validation at SimpliSafe. You help design and build SimpliSafe’s RF capabilities in our goal to have the best-in-class wireless connectivity...
Full time
Work at office
Simplisafe
Boston, MA
1 day ago
Computer Systems Validation Engineer
$80k - $120k
...and more accessible for all. To learn more about Care Access, visit How This Role Makes a Difference The Computer System Validation Engineer is responsible for ensuring that computerized systems used across the organization are validated, maintained, and compliant...
Full time
Temporary work
Work at office
Local area
Remote work
Worldwide
Visa sponsorship
Work visa
Flexible hours
Care Access
Boston, MA
15 days ago
Validation Lead
...Valspec is seeking a Validation & Compliance Lead to steer risk-based validation strategy and regulatory compliance for a major greenfield pharmaceutical manufacturing program on the East Coast. You will guide the program's qualification philosophy and ensure data integrity...
Valspec
Boston, MA
1 day ago
Validation Engineering
$105k - $130k
...Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY Genezen is hiring a Validation Engineer II/III to support validation and manufacturing operations by executing and documenting equipment, utility, facility, and...
Live in
Work at office
Visa sponsorship
Genezen
Lexington, MA
17 days ago
GxP Validation Engineer/Analyst (Lab Equipment)
.../completed remediation · Performing supporting remediation work in the form of SOP revisions · Executing change controls and validation test plans/protocols when required per remediation plans · Responsible for the development and execution of general deliverables...
Temporary work
WHITE COLLAR TECHNOLOGIES INC
Cambridge, MA
25 days ago
Power Engineer
Tenstorrent is leading the industry on cutting-edge AI technology, revolutionizing performance expectations, ease of use, and cost efficiency. With AI redefining the computing paradigm, solutions must evolve to unify innovations in software models, compilers, platforms,...
Permanent employment
Tenstorrent
Boston, MA
9 hours ago
Senior Advanced Manufacturing Engineer
: To reinvent an industry, you have to build the best team. Join Formlabs if you want to bring groundbreaking professional 3D printers to the desktop of every designer, engineer, researcher, and artist in the world. Our passion is designing and building powerful ...
Full time
Contract work
Work at office
Overseas
Flexible hours
Formlabs
Somerville, MA
7 days ago
Senior Engineer II, Downstream Manufacturing Science & Technology (MSAT)
...manufacturing network. This role serves as the downstream process SME supporting commercial manufacturing, technology transfer, PPQ/process validation, CPV, investigations, change control, regulatory support, and lifecycle management. The ideal candidate brings strong...
Scholar Rock
Cambridge, MA
4 days ago
Engineering/ Manufacturing Tech
...develop and improve injection molded and assembled products and processing thru numerous manufacturing steps.Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations.Provide troubleshooting focus and direction for the team with details of...
Nanobiosym
Cambridge, MA
a month ago
Engineering/ Manufacturing Tech
...processing thru numerous manufacturing steps.Develop and assist in the process and product monitoring, including the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations.Utilizes Lean principles to develop creative, thorough and practical...
Nanobiosym
Cambridge, MA
a month ago
Manufacturing Engineering Contractor
At Materion, everyone is included, respected and offered opportunity to grow. Join us! POSITION SUMMARY This position is key in driving manufacturing process improvements with the goal of optimizing safety, quality, and efficiency. This includes teaming with ...
Permanent employment
Full time
For contractors
Local area
Hire Velocity
Newton, MA
3 days ago
Test Automation Engineer
$115k - $130k
Test Automation EngineerLocation: Boston, MALess complexity. More dentistry. More impact.At Videa, we help dental clinicians deliver better care to millions of patients through AI.Oral health is health. Dentists are protectors of societal wellness. We build technology that...
VideaHealth
Boston, MA
3 days ago
Test Developer
Senior Open Test Vignette DeveloperE*Pro Consulting service offerings include contingent Staff Augmentation of IT professionals, permanent recruiting, and temp-to-hire. Our industry expertise and knowledge within financial services, insurance, telecom, manufacturing, technology...
Permanent employment
Full time
Temporary work
Flexible hours
E-Pro
Boston, MA
3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Validation Specialist. Be the first to apply!