Process Engineer

Arcadis; Framingham (MA); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

A global EPCM firm is seeking a CQV Engineer to support projects in New Bedford, MA. The role involves developing and executing equipment validation protocols within a cGMP and FDA regulated environment. Candidates should have 3-5 years of Equipment Validation experience and a strong understanding of automated systems. The position also requires preparation of validation documentation and resolution of validation-related issues, ensuring compliance with industry standards.

Formación

• 3-5 years of Equipment Validation experience in a cGMP & FDA regulated environment.
• Experience with CQV activities for equipment.
• Strong understanding of equipment and automated systems.

Responsabilidades

• Familiarize with user and functional requirements.
• Develop equipment validation protocols.
• Execute equipment validation protocols.
• Prepare validation documentation.
• Support resolution of validation-related issues.

Conocimientos

Equipment Validation experience

cGMP & FDA knowledge

Protocol development

Documentation management

Descripción del empleo

Summary

DPS is looking for a CQV Engineer to work for a client in New Bedford, MA

Key Responsibilities

• Become familiar with the user, functional, installation, operation and performance requirements for assigned projects and tasks.
• Review requirements and source documentation P&IDs, RDs, URSs, SOPs, Specifications for use in development of equipment commissioning and validation documents.
• Equipment validation protocol development, including drafting documents, managing review cycles and protocol approval.
• Support Validation Master Plan development.
• Execution of equipment validation protocols (including use of Kaye Validator/temperature monitoring for autoclaves, SIP Systems, washer COP, CIP, FITs, etc.).
• Support Equipment Validation Report development, including drafting documents, managing review cycles and protocol approval.
• Support Validation Summary Report development.
• Preparation and processing of turnover packaging and validation documentation in EDMQ (electronic document management system).
• Provide support for generation, resolution and closure of Equipment Validation related deviations and required documentation.
• Assist with coordination of activities between Client teams (validation, engineering, manufacturing, QC, etc.).
• Support resolution of engineering/validation issues found during equipment validation.
• Attending meetings as required to support equipment installation and operation.
• Providing quality oversight and approval for validation documents as needed (Function test, IQs, OQs, etc.).
• Support developing SOP’s.
• Other tasks as requested or required by Client to support Equipment Validation for each project.

Skills & Qualifications

• 3-5 Years of Equipment Validation experience working within a cGMP & FDA Regulated environment.
• Previous experience with CQV activities for equipment outlined above.
• Supporting engineer will be resident at the Client facility or a previously agreed upon location (i.e. vendor’s location).
• A strong understanding and knowledge of equipment and automated systems is desired.
• Support to be performed as required by the project schedules.
• Previous Experience working in a cGMP and FDA regulated environment.

Company

DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.

Equal Opportunity Employer

DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.