Validation Engineer
inSync Staffing
Job Title: Validation Engineer Location: Boston/Cambridge, MA Industry: Cell & Gene Therapy / Life Sciences Job Description:
We are seeking a Validation Engineer to support qualification, requalification, and validation activities within a GMP-regulated Cell and Gene Therapy facility. This role will focus on ensuring facilities, utilities, equipment, and systems meet applicable quality and regulatory requirements. Responsibilities:
We are seeking a Validation Engineer to support qualification, requalification, and validation activities within a GMP-regulated Cell and Gene Therapy facility. This role will focus on ensuring facilities, utilities, equipment, and systems meet applicable quality and regulatory requirements. Responsibilities:
- Develop, review, and execute validation and qualification protocols, plans, and reports
- Support requalifications, periodic assessments, and CQV projects
- Qualify facilities, utilities, laboratory equipment, and manufacturing systems
- Perform risk and impact assessments as needed
- Collaborate with Engineering, QA, EHS, Project Management, and other cross-functional teams
- Coordinate vendors supporting validation activities
- Ensure compliance with cGMP, SOPs, GAMP, ISO, CFR, and applicable standards
- Support continuous improvement and right-first-time documentation practices
- Bachelor's degree in Engineering or a related technical field
- 3-8 years of Validation/CQV experience in a GMP environment
- Experience writing and executing qualification protocols
- Knowledge of GMP, CFR, ISO, GAMP, and related standards
- Strong technical problem-solving and communication skills
- Ability to work independently and adapt to changing priorities
- Health insurance
- Health savings account
- Dental insurance
- Vision insurance
- Flexible spending accounts
- Life insurance
- Retirement plan
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Validation Engineer in Morrisville, NC vacancy
- ...2892576Reference26-01523 Responsibilities: Client is seeking validation consultants to support a 9-month minimum onsite project in South... ...effort moving forward. Requirements: Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred...Suggested
- ...Execution & Safety- Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety- Deliver C&Q... ...testingQualifications and Experience- Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can...SuggestedFull timeFor contractorsWorldwide
- ...Job Description Job Description Description: Alliance Biotech Solutions is currently hiring multiple Cleaning Validation Engineers to supports the execution and coordination of cleaning validation activities across manufacturing equipment and processes in GMP-regulated...SuggestedFull timeTemporary workCurrently hiringFlexible hours
Alliance Biotech Solutions LLC
Raleigh, NCa month ago - ...Description Job Description Valspec—a global provider of system validation and lifecycle services—provides commissioning and... ...the discovery of new and innovative therapies. Senior CQV Engineer (Cleaning Validation & Data Integrity) Location: Lexington,...SuggestedDaily paidContract workImmediate start
Valspec
Raleigh, NC23 days ago - Job-ID33094734Reference26-01777Job Description: Our client is seeking a Process Validation Engineer to support activities within a GMP pharmaceutical manufacturing environment. This individual will be responsible for developing, executing, and documenting process validation...SuggestedFull time
- ...Job Overview We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe...Long term contract
Stark Pharma Solutions Inc
Raleigh, NC1 day ago - Job-ID32575457Reference26-01231Remote50% Remote Job Description: We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and...Remote work
$105.5k - $243k
...Position SummaryWe are seeking a highly motivated ASIC Verification Engineer to join our networking silicon development team.Key... ...Cadence Xcelium, Synopsys VCS, Mentor Questa) and debug waveforms to validate design functionality.Collaborate with cross-functional teams to...Full timeWork experience placementWork at officeLocal areaImmediate start2 days per week- ...Job Description Job Description Job Title: Process Validation Engineer 3/Industrial Engineer Job Id: 26-04678 Location: Durham, NC Duration: 12 Months Contract Position Type: Hourly Contract Position (W2 only) Onsite, 5 Days a week Summary: This...Hourly payContract workLocal area
Sunrise Systems Inc
Durham, NC3 days ago - ...Team Novo Nordisk and help us make what matters.The PositionPlan, manage & perform low to moderately complex validation projects and activities. Support engineers with writing change requests and conducting/writing deviation investigations. Support validation activities...Work at officeLocal area
- ...Job Description Job Description Description: Alliance Biotech Solutions has multiple openings for Validation Engineers to support the execution and coordination of commissioning, qualification, and validation (CQV) activities for new and existing equipment within...Full timeTemporary work
Alliance Biotech Solutions LLC
Raleigh, NCa month ago - ...a real difference in healthcare and enterprise environments worldwide. We are now looking for a highly skilled and motivated Test Engineer (R&D) to join our Morrisville based R&D team. If you are passionate about quality, automation, and building reliable software and...Full timeWorldwide
Ascom
Morrisville, NCa month ago $107.1k - $160.7k
...the world’s leading integrated design practice. Our architects, engineers, interior designers, consultants, sustainability specialists,... ...support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and facilities...Full timeTemporary workPart timeCasual workWork at officeLocal areaImmediate startFlexible hours- ...01404 Job Description: We are seeking an experienced Senior Validation Specialist to lead qualification and validation activities in... ...regulatory inspections and internal/external audits. Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory...
$136k - $218.5k
NVIDIA is seeking an outstanding Senior ASIC Verification Engineer to verify the design and implementation of the world’s leading SoC's and GPU's. This position offers the opportunity to have a real impact in a dynamic, technology-focused company impacting product lines...Full time$119.8k - $234.7k
...MicrosoftOverviewMicrosoft Silicon, Cloud Hardware, and Infrastructure Engineering (SCHIE) is the team behind Microsoft’s expanding Cloud... ...with and influence architects, logic designers, post-silicon validators, other verification engineers, and IP and tool providers....Ongoing contractPermanent employmentWork at officeLocal areaWorldwide3 days per week- ...small teams in document development and/or execution Qualifications and Experience - Bachelor’s degree in a science or engineering field (or equivalent experience) - 2–4 years’ experience in commissioning and qualification in a regulated industry -...Worldwide
- ...patients with severe neurological disorders. The company’s vector engineering platform enables potent and cell-type-selective regulation of... ...readiness across various processing scales. Equipment Validation and Onboarding - Support Factory/Site Acceptance Testing (FAT...Relocation packageShift workNight shift
Encoded Therapeutics
Morrisville, NCa month ago $136k - $218.5k
...the team and see how you can make a lasting impact on the world.We're looking for a talented, motivated Senior Design Verification Engineer to join our GPU memory subsystem team in Durham, NC. Looking to join a dynamic team solving complex verification challenges...Full time$102.1k - $202.2k
...MicrosoftOverviewMicrosoft’s Silicon, Cloud Hardware, and Infrastructure Engineering (SCHIE) is the team behind Microsoft’s expanding Cloud... ...importance. To achieve this goal, the Verification & Validation (Verif&Val) team is instrumental in defining and delivering operational...Ongoing contractPermanent employmentWork at officeLocal areaWorldwide3 days per week$168k - $264.5k
...work. Come join the team and see how you can make a lasting impact on the world.NVIDIA is seeking best-in-class ASIC Verification Engineers to verify the design and implementation of the world’s leading inference accelerator. This position offers the opportunity to have...Full time- ...THE WORK: Support delivery of Industrial and Automotive reinvention, with a focus on realizing complex large scale manufacturing engineering initiatives. This includes transformation of large brownfield plants, design of greenfield plants and preparing for new product launches...Full timeWork experience placementLive inWork at officeLocal area
- ...Overview Join a highly collaborative and innovative engineering team supporting Product Verification & Validation (PV\&V) for electric machines used across a wide range of heavy equipment —including tractors, construction machinery, turf and golf products, and more. This...Full time
Pentangle Tech Services | P5 Group
Raleigh, NC2 days ago $136k - $218.5k
...see how you can make a lasting impact on the world.NVIDIA is seeking a Senior ASIC Compose Verification Infrastructure and Tools Engineer to advance the systems that qualify, integrate, and deliver complex ASIC IP across multiple products. This role is ideal for an RTL...Full time- ...Responsible for supporting all aspects of the Computer Systems Validation (CSV) Lifecycle for the Validation Department to ensure all... ...Audit Observations. Minimum Requirements Bachelor’s degree in Engineering or Information Technology discipline. Master’s Degree...Work at officeImmediate start
$103.99k - $219.36k
...biggest challenges in an ever-evolving world. With over 100 years of innovation in sustainable infrastructure and our expertise in engineering, procurement, consulting and construction, together we are building a world of difference.Company : Black & Veatch CorporationReq...Part timeWork experience placementWork at officeLocal areaRelocationVisa sponsorshipFlexible hours$70.49k - $109.9k
...constantly acquire new skills and learn from our experiences to enhance our collective expertise Senior CQV Engineer Responsibilities: Designing validation plans Conducting and documenting impact and risk assessments with a full understanding of equipment/...Temporary workWork experience placementWork at office$107.8k - $168.01k
...collective expertise We are seeking a Solution Prep Principal Engineer with hands-on experience supporting solution preparation... ...unit operations, supporting commissioning, qualification, and validation activities to ensure systems are designed, installed, tested,...Temporary workWork experience placementVerista, Inc.
Apex, NC23 days ago- ...biggest challenges in an ever-evolving world. With over 100 years of innovation in sustainable infrastructure and our expertise in engineering, procurement, consulting and construction, together we are building a world of difference. Company : Black & Veatch...Full timeContract workPart timeWork experience placementInternshipSummer internshipWork at officeRelocationVisa sponsorshipFlexible hours
- ...Here’s the Gist: We are seeking an experienced and highly motivated individual to take on the challenging role of Product Quality Engineer for our growing silicon carbide Power business. This person will be responsible for driving improvement in customer satisfaction by...Full timeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Validation Engineer. Be the first to apply!
Related searches