Specialist Tech Engineering

Veg Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. specializes in validation, engineering, and compliance for pharma, biotech, chemical, food, and medical devices. The Specialist Tech Engineering provides technical support for system optimization, upgrades, and regulatory compliance across maintenance operations.

The role emphasizes leadership, validation protocol knowledge, and collaboration with the maintenance and plant engineering teams to uphold FDA standards and continuous improvement initiatives.

Qualifications

• Educational background in science or engineering with strong regulatory exposure.
• Experience in pharmaceutical/biotech/medical devices industries.
• Proficiency with validation protocols and regulatory guidance.
• Experience in maintaining compliant equipment and systems.
• Fluency in English and Spanish is a plus; strong technical writing skills.

Responsibilities

• Ensure maintenance and calibration programs meet industry and FDA standards.
• Maintain training programs and SOP consistency across the maintenance team.
• Coordinate engineering support for regulatory, calibration, quality, and validation issues.
• Support inspections from FDA and other regulators.
• Assist in evaluating engineering improvements and compliance initiatives.
• Lead investigations and audit program development for maintenance activities.
• Collaborate with Plant Engineering on process and utility system optimizations.

Skills

Leadership

Verbal communication

Written communication

Validation protocol knowledge

Technical (Equipment)

Analytical problem solving

Project management

Education

Bachelor's Degree in Science or related field

Master’s degree in Engineering

Tools

Maximo

SAP

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

Description:

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 and SAP 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.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.