MF01-112425 PD Validation Engineer (Medical Devices)

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Validation Engineer – Process Development

  Purpose Statement

  Engineer, Validations: Develops and reviews documentation and procedures, and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering.

  Key Responsibilities:

• Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
• Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures.
• Design and develop in-process and receiving quality systems for new processes and components.
• Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required.
• Define gages, tools and equipment for the test methods developed.
• Generate manufacturing instructions for new processes being developed.
• Work cross-functionally with other departments to accomplish PD tasks.

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 3 - 5years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in medical devices operations.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
• SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
• Strong knowledge (according to related area).
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.