Katalyst Healthcare & Life Sciences

Clinical trial management software and consulting

Validation Engineer

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours

Full-timeNorth Haven, CT, USANo salary listedIn-person

About the Job

Requirements

A bachelor's degree and at least 5–7 years of experience in a regulated environment, or an advanced degree and at least 3 years of experience.
A minimum of 5 years of professional experience in a relevant field.
Experience with Agile PLM and SAP or BPCS enterprise resource planning systems.
Experience with computer-aided design models using SolidWorks or AutoCAD.
Experience with new product introduction and design transfer deliverables for injection-molded components.
Experience within a highly regulated industry.
Hands-on experience within production and enterprise environments.

Responsibilities

Facilitate or perform validation and qualification activities to support the release of high-quality injection-molded components in collaboration with sites around the world.
Qualify suppliers and their processes to ensure they meet requirements for producing high-quality, reliable products.
Develop and execute validation plans, conduct audits, and manage the overall Production Part Approval Process to ensure compliance with ISO 13485 and medical standards.
Write, review, and approve validation change controls, validation protocols, installation qualification, operational qualification, performance qualification, process validation, standard operating procedures, standard calibration methods, standard test methods, specifications, corrective and preventive actions, and exception reports.
Accurately record and manage validation processes in compliance with internal standard operating procedures and external regulations.
Review test results and measurements to identify discrepancies, including using statistical process control.
Apply knowledge of ISO 13485, FDA Good Manufacturing Practices, ISO 14971, and FDA Code of Federal Regulations Title 21 Part 820.
Communicate with stakeholders and obtain their engagement to ensure the end products or processes solve business problems.

Desired Qualifications

Clean room experience and medical product manufacturing experience are advantageous.

Job Description

Responsibilities:

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.

Requirements:

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.

Qualifications

Additional Information

All your information will be kept confidential according to EEO guidelines.

About the Company

Katalyst Healthcare & Life Sciences

Clinical trial management software and consulting

Katalyst Healthcare & Life Sciences offers EasyCDM Suite, a Clinical Trial Management Solution paired with consulting services to manage the full trial lifecycle. The platform covers study design, electronic data capture, medical coding, and data management, with implementation and optimization support from a consulting team. It differentiates itself by providing an all-in-one, configurable suite combined with industry-specific consulting across pharma, biopharma, medical devices, cosmeceuticals, and food/bev sectors. Its goal is to simplify business challenges and accelerate safe, effective development to improve global health.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: South Plainfield, NJ
Founded: 2016

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