CSV Engineer

Katalyst Healthcares and Life Sciences

Winchester, MA

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 System Validation (CSV) documentation and validation protocols for QC laboratory systems and manufacturing systems.
Support the complete validation lifecycle, including preparation, execution, review, and approval of User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Risk Assessments, and Validation Reports.
Perform risk assessments to identify and mitigate validation and compliance risks.
Ensure compliance with GAMP 5, 21 CFR Part 11, GMP, and internal quality standards.
Review validation documentation to ensure accuracy, completeness, and regulatory compliance.
Collaborate with Quality Assurance (QA), Manufacturing, Engineering, and IT teams to support validation activities and system implementations.
Provide validation support for QC laboratory systems and manufacturing equipment throughout their lifecycle.
Assist with change control, deviation investigations, and periodic reviews related to validated systems.
Maintain accurate validation records and ensure documentation is audit ready.
Support internal and external regulatory inspections by providing validation documentation and technical expertise.

Requirements / Qualifications:

Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or a related field.
Experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment.
Strong knowledge of GAMP 5, 21 CFR Part 11, and GMP regulations.
Hands-on experience supporting QC laboratory systems and/or manufacturing equipment validation.
Experience developing and reviewing validation lifecycle documentation, including URS, IQ, OQ, PQ, Risk Assessments, and Validation Reports.
Experience working collaboratively with Quality Assurance (QA), Manufacturing, Engineering, and IT teams.
Strong understanding of the CSV lifecycle, risk-based validation, and documentation best practices.
Excellent technical writing, documentation, communication, and problem-solving skills.
Ability to manage multiple validation activities while maintaining compliance with regulatory and quality requirements.

Apply

Vacancy posted 2 days ago

Similar jobs that could be interesting for youBased on the CSV Engineer in Winchester, MA vacancy

CSV Engineer
...Computer System Validation Engineer 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,...
Suggested
Katalyst HealthCares & Life Sciences
Woburn, MA
5 days ago
CSV Engineer
...Computer Systems Validation Engineer The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems... ...in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing...
Suggested
Work at office
Katalyst HealthCares & Life Sciences
Cambridge, MA
2 days ago
Senior CSV Validation Engineer
$115k - $140k
...is appropriately documented Support quality events involving CSV in protocol nonconformances, deviations, investigations, CAPAs,... .../ LICENSES ~ A minimum of a bachelor's degree in Engineering, Computer Science or related discipline ON-THE-JOB EXPERIENCE...
Suggested
Contract work
Live in
Work at office
Visa sponsorship
Genezen
Lexington, MA
29 days ago
Optical/Electronics Engineer-Associate Staff
...processing skills to enable the testing and evaluation of systems under design.Minimum QualificationsMaster's degree in electrical engineering, physics, or equivalent. In lieu of a Master's degree, a Bachelor's degree and 3+ years of experience will be considered....
Suggested
Lincoln Laboratory
Lexington, MA
2 days ago
On-Site IT Field Engineer (Level 2) - MSP Support
Bit By Bit Inc is seeking a Level 2 Field Engineer to join our on-site team. This on-call role based in New Jersey involves working directly with clients, managing installations, troubleshooting, and providing ongoing technical support while coordinating with the broader...
Suggested
Casual work
Bit by Bit Inc
Somerville, MA
3 days ago
National Multi-Site Civil Engineering Director
Core States Group is seeking a Senior Director of Civil Engineering - Multi-Site to lead national multi-site Civil Engineering teams, shaping performance, growth, and delivery standards. The role requires strategic orientation, execution discipline, and the ability to develop...
Core States Group
Burlington, MA
4 days ago
Validation Engineer
...Roles & Responsibilities: We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing... ...Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5. A solid working knowledge of...
Katalyst HealthCares & Life Sciences
Somerville, MA
2 days ago
Field Systems Engineer
...Field Systems Engineer Viken Detection is a leading provider of advanced analytical and security detection solutions. Our innovative x-ray and elemental analysis technologies help customers around the world make critical decisions in security screening, threat detection...
Full time
Work at office
Local area
Remote work
Worldwide
Relocation package
Viken Detection
Burlington, MA
3 days ago
HVAC Engineer
$2,000 per month
...HVAC Engineer Design. Innovate. Build. Grow. Cummings Properties is looking for a skilled and motivated HVAC Engineer to join our in-house Architectural/Engineering team in Woburn, MA. If you have 10+ years of experience and thrive in a fast-paced, hands-on, design/build...
Local area
Cummings Properties
Woburn, MA
3 days ago
Principal Radar Systems Engineer
$204k - $284k
...Systems Development Division (SDD) within STR delivers technology advantage into users’ hands and is seeking a Principal Radar Systems Engineer to support/lead the architecting, design, development, and implementation of radar systems that meet challenging customer needs....
Full time
Work experience placement
Local area
Night shift
STR
Woburn, MA
3 days ago
Manufacturing Automation Engineer
Job TitlePosition Summary: Own and improve the reliability of production equipment by troubleshooting and sustaining electromechanical, controls, and firmware-adjacent systems across OPT's manufacturing floor.Key Responsibilities:Own and develop Python-based control, test...
Opt Industries
Medford, MA
3 days ago
Principal Process Engineer (SMT Manufacturing)
$62.5k - $245k
...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 time
Local area
Draper
Somerville, MA
2 days ago
Manager, Automation Engineering
$130k - $160k
...Manager, Automation Engineering The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials...
Work experience placement
Visa sponsorship
Genezen
Lexington, MA
2 days ago
Staff Mechanical Engineer
...seeking a talented, enthusiastic, and creative individual with a solid background in mechanical design and analysis to join our Engineering Services group. You will join a diverse engineering team and develop new, cutting-edge products for our customers and the Optikos...
Work at office
Worldwide
Visa sponsorship
Work visa
Optikos Corporation
Wakefield, MA
2 days ago
Senior Automation & Controls Engineer
...into carbon-negative fuels and chemicals like green methanol and green ammonia. Leveraging our patented technology, we transform car engines into cost-effective, modular chemical plants. This groundbreaking approach enables us to support various industries, including...
Full time
Contract work
Immediate start
Remote work
Work visa
Emvolon
Woburn, MA
2 days ago
Senior Civil Engineer/Project Manager
$125k - $180k
...Description Your role at GEI. We are seeking a Senior Civil Engineer/Project Manager with project management, business development, and large civil project experience to join our team. This individual will support our growing civil engineering practice...
Contract work
Work at office
Local area
Flexible hours
Night shift
GEI Consultants
Wakefield, MA
1 day ago
Service Engineer
$66.59k - $108.64k
...Technical SupportPhoenix,ArizonaWoburn,Massachusetts Salary: USD 66585.00 - 108638.00 Annually As a Service Engineer, you will play a key role in enhancing the customer experience by serving as a frontline representative of the company and helping clients utilize FTR...
Tyler Technologies
Woburn, MA
2 days ago
Senior Manufacturing Engineer - CNC / Multi-Axis / Process Development
$110k - $150k
...ensuring that what works in development translates into repeatable, production-ready success. At Rennscot, the Senior Manufacturing Engineer is not just solving problems—they are: Defining how work gets done Building systems that scale Elevating the technical...
Permanent employment
Full time
Monday to Friday
Shift work
Day shift
Rennscot MFG
Woburn, MA
14 days ago
Civil Engineer Project Manager
...Project Manager (Civil Engineer) This is a full-time in-office role for a Project Manager (Civil Engineer) located in Stoneham, MA. The Civil Engineer will be responsible for civil engineering design, planning, storm water management, and collaborating with other disciplines...
Full time
Work at office
Futran Tech Solutions Pvt. Ltd.
Stoneham, MA
2 days ago
Civil Engineer
...Civil Engineer We are well-established engineering team seeking a Civil Engineer to support site development, land development, and municipal infrastructure projects. This role offers strong exposure to design, permitting, and project coordination. Key Responsibilities...
For contractors
NESC Staffing Corp.
Woburn, MA
5 days ago
Electrical Engineering Manager
$165k - $175k
...Electrical Engineering Manager, Burlington, MA area US Citizenship is required, no sponsorship possible for this position. Background check and drug test are required. Position Summary The Electrical Engineering Manager will lead the electrical engineering team in designing...
For contractors
Local area
GCR Professional Services
Burlington, MA
5 days ago
Computer Numerical Control Programmer
Seeking an experienced fabrication specialist and machinist with expertise in complex parts development, providing autonomy over their fabrication approach, fixture design/fabrication, tooling, CAM programming, setup, and machine operation. The ideal candidate is a talented...
John Galt Staffing
Lexington, MA
3 days ago
Staff Mechanical Engineer
$150k
...Staff Mechanical Engineer Founded by Dr. Jonathan Rothberg in 2011, Butterfly Network is a digital health company with a mission to democratize medical imaging by making high-quality ultrasound affordable, easy-to-use, globally accessible, and intelligently connected...
Full time
Work at office
Local area
Remote work
Work visa
Butterfly Network
Burlington, MA
3 days ago
Senior Mechanical & Controls Engineer (Electrochemical)
Blueshift in Somerville, MA, is seeking a Senior Engineer to design mechanical and control systems for electrochemical technology. You will develop scalable, cost-effective solutions and drive prototyping, testing, and integration from concept through deployment. The role...
For contractors
Blueshift
Somerville, MA
2 days ago
Project Engineer - Concrete Tank Construction
A leading construction services provider is seeking a Project Engineer in Wakefield, Massachusetts. In this role, you will assist Project Managers to achieve project success while managing various construction phases. Ideal candidates will have a Bachelor's degree in Civil...
For subcontractor
DN LLC
Wakefield, MA
1 day ago
Electrical & Controls Engineer
...Electrical & Controls Engineer We are seeking an Electrical & Controls Engineer to support the development and execution of capital projects featuring Lithios' Advanced Lithium Extraction (ALE). The ideal candidate has at least 5 years of relevant experience with...
For contractors
Lithios
Medford, MA
3 days ago
Principal Mechanical Design Engineer
$62.5k - $237.5k
...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 time
Local area
Draper
Somerville, MA
2 days ago
Advanced Test Engineer
$114k - $142k
...As an Advanced Test Engineer here at Honeywell Aerospace, you will play a pivotal role in designing, developing, and executing advanced test methodologies to ensure the quality and reliability of aerospace products. You will collaborate closely with cross-functional teams...
Temporary work
Work experience placement
Relocation package
Flexible hours
Honeywell Aerospace
Woburn, MA
3 days ago
Embedded Test Engineer
$54.3k - $108.16k
...Embedded Test EngineerAt Capgemini Engineering, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. Join us for a career full of opportunities. Where you can make a difference....
Full time
Local area
Capgemini
Burlington, MA
4 days ago
Hardware Test Engineer
$98k - $130k
...computer vision, sensor fusion, and networking technology to the military in months, not years.ABOUT THE JOBAs a Laser/Camera Test Engineer you will be responsible for ensuring that we are testing our systems to stringent standards ensuring that we are consistently...
Full time
Work experience placement
Immediate start
Anduril Industries
Lexington, MA
2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to CSV Engineer. Be the first to apply!