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Validation & Engineering Group, Inc.

LL01-071924 Specialist Tech Engineering

Validation & Engineering Group, Inc., Juncos, Juncos, us, 00777

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Specialist Tech Engineering Validation & Engineering Group, Inc.

(V&EG) is a leading services supplier that provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in areas such as 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:

Job Description The Specialist Tech Engineering will provide technical engineering support on all system and equipment optimization strategies, upgrades, replacements, and modifications. They will ensure that all maintenance team operations and activities are maintained in compliance with corporate policies, industry standards, regulatory standards, and FDA standards. Responsibilities include:

Ensuring utility systems, process maintenance, instrumentation/calibration/electrical systems, and technical cleaning systems comply with applicable industry, regulatory, and FDA standards.

Maintaining the maintenance team training program, standard operating procedures, and equipment/system operational standards.

Coordinating technical support to the maintenance team on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process maintenance issues.

Providing technical support during FDA and other regulatory agency inspections and responses.

Supporting the maintenance team in response to high purity water systems and environmental monitoring alert/action notifications, and investigating alerts/actions.

Developing and maintaining an audit program for the maintenance team and facilitating routine audits of activities, documentation, operations, and related areas.

Assisting plant engineering in evaluating and implementing engineering improvements, policy changes, compliance improvements, and optimization programs.

Evaluating sanitization and maintenance procedures, proposing changes to the Department Manager, and proposing modifications for process, utility, and clean room systems to the Plant Engineering Group.

Education & Experience Master’s degree & 3 years of Engineering experience OR Bachelor’s degree & 5 years of Engineering experience.

Must Have Skills

Leadership and team building

Verbal communication

Written communication / Technical writing

Organization, facilitation, dealing with and managing change.

Position Details Seniority level: Mid-Senior level. Employment type: Full-time. Job function: Strategy/Planning and Information Technology.

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