Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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:

• Specialist Tech Engineering

The Specialist Tech Engineering will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards.

Responsibilities:

• Ensure utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.
• Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
• Coordinate technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and process maintenance issues.
• Provide technical support for the maintenance team during FDA and other regulatory agency inspections.
• Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
• Support the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications.
• Support the investigation on all alert/action notifications. Support the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations and related areas to ensure a continued state of compliance.
• Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
• Evaluate sanitization and maintenance procedures.
• Propose changes to the Department Manager.
• Propose modifications for process, utility and clean room systems to the Plant Engineering Group.

Education:

• Master’s degree & 3 years of Engineering experience
• Bachelor’s degree & 5 years of Engineering experience

Skills:

• Leadership and teambuilding,
• Verbal communication.
• Written Communication/Technical Writing
• Comprehensive understanding of validation protocol requirements
• Technical (Equipment Specific)
• Analytical Problem Solving Project Management.
• Vast experience in Maximo is required.

Qualifications:

• Bachelor's Degree in Science or related field.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• 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.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.