Full-Time
Validation Engineer
Katalyst Healthcares & Life Sciences
51-200 employees
Clinical trial management software and services
No salary listed
North Haven, CT, USA
In Person
 QA & Testing (1) |
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- Bachelor's degree with a minimum of 5-7 years of experience in a regulated environment, OR an advanced degree with a minimum of 3 years of experience
- Minimum of 5 years of professional experience in a relevant field
- Experience with Agile PLM and SAP or BPCS ERP systems
- Experience with CAD model with use of Solid Works or AutoCAD
- Experience with NPI and design transfers deliverables for injection moulded components
- Experience within highly regulated industry
- Hands on experience within production and enterprise environment
- As a Validation Engineer within the Mold & Capital Tooling Organization, you'll play a pivotal role on a global enterprise team, collaborating with various sites around the world. In this role, you'll facilitate or perform critical validation & qualification activities, ensuring the seamless release of high-quality injection molded components that drive our mission forward.
- Ensure proper qualification and validation of suppliers and their processes, ensuring supplier meets the requirements for producing high-quality, reliable products.
- Developing and executing validation plans, conducting audits, and managing the overall PPAP process to ensure compliance with ISO 13485/ Medical standards.
- Write, review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures, standard calibration methods, standard test methods, specifications CAPAs and exception reports.
- Strong documentation skills - Accurately recording and managing validation processes in compliance with internal SOPs and external regulations.
- Review test results and measurements to identify discrepancies.
- SPC (Statistical Process Control).
- Knowledge on ISO 13485, FDA GMP, ISO 14971, FDA CFR 820.
- Clean Room experience and medical prod mfg exp (added advantage).
- Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.
Katalyst Healthcares & Life Sciences provides a Clinical Trial Management Solution called EasyCDM Suite that covers the full lifecycle of clinical trials. The product supports study design, data capture, medical coding, and data management to streamline processes for clients in pharmaceutical, biopharmaceutical, medical device, cosmeceuticals, and food and beverage industries. The system works by organizing trial data in a unified platform, enabling electronic data capture (EDC), coding, data validation, and workflow management, while consulting services assist with implementation and optimization. The company differentiates itself through a combined offering of software, consulting, and services that aim to accelerate drug development while maintaining quality and safety standards. The goal is to simplify business challenges, maximize human potential, and improve health outcomes worldwide through life science innovations.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
South Plainfield, New Jersey
Founded
2016
Simplify's Take
What believers are saying
- Hiring 735 positions signals strong contract staffing expansion.
- Global CRO services enhance competitive positioning worldwide.
- Active jobs in Burlington MA, Newark NJ, San Diego CA diversify geography.
What critics are saying
- Medidata Rave and Veeva Vault erode EasyCDM sales in 12-24 months.
- FDA 2025 AI mandate forces EasyCDM upgrades or client loss in 6-12 months.
- Oracle-Certara acquisition outcompetes consulting contracts in 18-24 months.
What makes Katalyst Healthcares & Life Sciences unique
- EasyCDM Suite streamlines clinical trials from study design to data management.
- Serves pharmaceutical, biopharma, medical devices, cosmeceuticals, and food sectors.
- Combines consulting services with EasyCDM for accelerated drug development.
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