Senior Validation & Engineering Specialist (Regulatory)

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. is looking for a Specialist Tech Engineering in Juncos, Puerto Rico. This role involves providing technical engineering support on system optimizations, ensuring compliance with industry and regulatory standards.

The ideal candidate will have a Master’s degree and 3 years of experience or a Bachelor’s degree with 5 years of experience in engineering, and must be fully bilingual in English and Spanish. Skills in Maximo and SAP are required.

Qualifications

• Bachelor's Degree in Science or related field.
• Minimum of 5 years of experience in direct pharmaceutical or biotechnology industries.
• Must be fully bilingual (English / Spanish).

Responsibilities

• Ensure compliance of maintenance operations with industry standards.
• Coordinate technical support to the maintenance team.
• Provide technical support during FDA inspections.

Skills

Leadership and team building

Verbal communication

Written communication/technical writing

Comprehensive understanding of validation protocol requirements

Analytical problem solving

Vast experience in Maximo and SAP

Education

Master’s degree in Engineering and 3 years of experience

Bachelor’s degree in Engineering and 5 years of experience

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.