CSV/CSA Compliance Engineer (FDA Regulated)
Novozen Healthcare LLC
Novozen Healthcare LLC is seeking a validation engineer to provide CSV/CSA compliance guidance across IT and business teams. You will lead risk-based validation efforts focused on patient safety, product quality, and data integrity. You will develop and harmonize validation documentation per GAMP 5 and CSA, assess new systems, and support audits and change control activities. Strong communication and mentoring skills are essential. #J-18808-Ljbffr Novozen Healthcare LLC
- ...Computer Systems Validation Engineer will be responsible for... ...and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily... ...Responsibilities: Provide CSV and CSA-based compliance... ...of CSV experience in an FDA regulated industry....SuggestedWork at office
$115k - $140k
...functional teams, ensuring compliance with regulatory... ...ensure compliance with FDA, EU, ISO, Data Integrity... ...events involving CSV in protocol nonconformances... ...bachelor's degree in Engineering, Computer Science or related... ...Understanding of cGMP regulations Strong technical...SuggestedContract workLive inWork at officeVisa sponsorship$100k
...Senior Quality Engineer Location: Devens, MA Job Type: Direct... ...Industry: Medical Device / Regulated Manufacturing Lead Quality. Drive Compliance. Make an Impact. Adecco is... ...experience in medical devices, FDA regulations, ISO standards, process...SuggestedFull timeTemporary workLocal area$115k - $145k
...Mechanical Engineer - Design and Build the Equipment Behind a Next-Generation Metal Casting Foundry *Billerica, MA | On-site* Opportunity... ...data controlled under the International Traffic in Arms Regulations (ITAR). Applicants must be U.S. persons (U.S. citizens or lawful...SuggestedPermanent employmentImmediate start$122k - $152k
...application process. Senior Process Engineer Bedford, MA, Bedford, MA,... ...operations. Working in a regulated manufacturing environment,... ...protective equipment, and compliance with Environmental, Health, and... ...field. Familiarity with FDA requirements, ISO 13485, and...SuggestedFull timeImmediate start- ...creativity.Position Summary:This position will serve as a mid-level engineer focused on drug product and process development in the... ...room environment to support clinical studies.Understand GMP regulation and FDA/EMEA guidance on manufacturing processes and apply them...Full timeLocal area
$93.6k - $135.7k
...need for a mid-Level Process / Chemical Engineer with 5 + years of engineering,... ...decisions.Lead interpretation and verify compliance with applicable codes and engineering standards... ...Stantec is in compliance with laws and regulations and ensures equitable opportunities in...Contract workWork at officeImmediate startWork from homeShift work- ...Quanterix in Billerica, MA, is seeking a Sr. Process Engineer to join the Process Development team. You will drive development and... ...designing experiments and advancing process characterization in an FDA-regulated environment. You will collaborate with Research, Technology...
- MKS Instruments seeks a Principal Product Compliance Engineer to lead regulatory product compliance across Plasma and Reactive Gas lines.... ...compliance/testing, with knowledge of LVD, EMC/EMI, and global regulations (FCC, CE, RoHS, REACH, CA65, EPA TSCA). #J-18808-Ljbffr...
$110k - $160k
A Day in Your Life at MKS: As a PRINCIPAL PRODUCT COMPLIANCE ENGINEER at MKS Instruments, you will partner with cross-functional technical... ...compliance testing Ensures product designs meet applicable regulation requirements including certification, ongoing testing and processing...Relocation package$110k - $160k
A Day in Your Life at MKS As a PRINCIPAL PRODUCT COMPLIANCE ENGINEER at MKS Instruments, you will partner with cross-functional technical... ...compliance testing. Ensures product designs meet applicable regulation requirements including certification, ongoing testing and processing...Permanent employmentRelocation package$110k - $160k
A Day in Your Life at MKS: As a PRINCIPAL PRODUCT COMPLIANCE ENGINEER at MKS Instruments, you will partner with cross-functional technical... ...compliance testing Ensures product designs meet applicable regulation requirements including certification, ongoing testing and processing...Permanent employmentRelocation package$23.47 - $34.5 per hour
...Opportunity Stantec is looking for a Process Engineer Intern to join our Facilities & Process... ...- $34.50 Hourly Pay Transparency: In compliance with pay transparency laws, pay ranges... ...Stantec is in compliance with laws and regulations and ensures equitable opportunities in...Hourly payFull timeTemporary workPart timeSummer workCasual workInternshipWork at officeLocal areaFlexible hours- ...supply base. You will work in close coordination with Product Engineering, Supply Chain and Production and Suppliers to execute... ...trends, customer complaints, industry standards and government regulations. Requirements: Bachelor Degree engineering (Master Degree is...
- Sr. Process Engineer Billerica, MA Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in... ...advance process characterization and scale-up methodology in an FDA-regulated environment. You will identify technical requirements in our...Remote workFlexible hours
- ...Parker Hannifin Corporation's Parker Chomerics division seeks a Senior Compliance Engineer to lead and maintain quality and regulatory programs. You will drive AS9100, ISO 9001, and IATF16949 compliance across engineering, manufacturing, and operations. You will oversee...Permanent employment
- ...E Ink Corporation is seeking a Senior Chemical Engineer to join the Process Development Team. You will design, build, and optimize pilot-scale systems enabling commercial production of electrophoretic materials—pigments, colloids, microcapsules, and additives—and drive...
- ...sponsorship in the future. **Job SummaryThe Mechanical Manufacturing Engineer is responsible for developing, implementing, and optimizing... ...factors including, but not limited to, location, local regulations (such as minimum wage), education/training, work experience, key...Minimum wagePermanent employmentFull timeWork experience placementLocal areaVisa sponsorshipWork visa
$107.1k - $160.7k
...seeking a highly motivated Senior Process Engineer with industrial and municipal... ...Salary $ 202,500.00Pay Transparency: In compliance with pay transparency laws, pay ranges... ...Stantec is in compliance with laws and regulations and ensures equitable opportunities in...Full timeContract workTemporary workPart timeFor contractorsCasual workLocal areaFlexible hours$146k - $194k
...not years. ABOUT THE TEAM: Our Quality Engineering team is a dedicated group of professionals... ...statistical process control within a regulated environment If you have strong... ...lifecycle Drive Quality Management System compliance & sustainability to the AS9100 certification...Full timeWork experience placementRelocation- ...Hydrogel Embolic System, is FDA-approved for hypervascular tumor... ...The Senior Manufacturing Engineer will be responsible for overseeing... ...efficient production and compliance with quality standards. Manage... ...In-depth knowledge of FDA regulations, ISO standards, and relevant...Work at officeShift work
- ...product, Embrace Hydrogel Embolic System, is FDA-approved for hypervascular tumor... ...Responsibilities: The Senior Advanced Manufacturing Engineer is a key technical contributor to... ...development for medical devices or a similarly regulated industry, with significant experience...Contract workWork at office
- ...Job Salary Range: 118,500.00 - 148,100.00Sr. Applied Research Engineer - Biomechanics - BurlingtonWhat You’ll Do:We are seeking a highly... ...successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.Local area
- ...audit readiness. Embed safety considerations into day-to-day engineering decisions with peers. Experiential Background: ~ BS in Engineering; exposure to functional safety or product compliance work. ~5+ years of practical experience in safety and compliance...
$120k - $140k
...Mechanical Engineer OpportunityDevelop innovative electromechanical products for industrial applications. Join a team supporting new... ...testing, and validation activities.Exposure to ISO, AS9100, or regulated manufacturing environments is a plus.What's on OfferSalary of...Local area- ...The Sr. Process Excellence Engineer , is responsible for driving... ...ensuring Quality processes enable compliance, operational excellence, and... ...requirements, standards, and regulations well and know how to... ...Health Canada, Brazil, China FDA, US FDA QMSR. Skills and...Work experience placementLocal area
- Anika seeks a Senior Process Engineer in Bedford, MA to lead process development, equipment implementation, and continuous improvement... ...FAT/SAT, and apply Lean/Six Sigma to enhance efficiency, quality, and reliability in a regulated environment. #J-18808-Ljbffr Anika
- ...in matters related to Validation and GxP compliance. · Ability to work in a fast-moving... ...other validation areas which may include CSV qualification and Facility Equipment and... ...System Validation · Bachelor's Degree in Engineering, Life Science or Computer Science is...Temporary work
- ...motivated and experienced Precision Manufacturing Engineering Lead to join and guide our growing team. In this leadership... ..., and throughput while ensuring quality control, compliance with applicable standards and regulations, and adherence to precision manufacturing practices...
$37 - $47 per hour
...Job Description Job Description Equipment Engineer II (On-Site) Location: Billerica, MA Duration: 6-Month Contract with the potential to extend or convert at any time. Pay Rate: $37–$47/hour Industry: Medical Device Manufacturing Build Better Equipment...Contract work
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