Sr Engineer

Veg Group; Carolina (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading engineering services provider in Carolina, Puerto Rico, is seeking a dedicated engineer to optimize processes and troubleshoot operational issues in the pharmaceutical and biotechnology sectors. The ideal candidate should possess at least 4 years of relevant experience, be bilingual in English and Spanish, and hold a Master's degree in Engineering. This role offers a unique opportunity to contribute meaningfully to the healthcare and technology sectors, working with a supportive team.

Qualifications

• Minimum of 4 years of experience in direct pharmaceutical, medical device, or biotechnology industries.
• Strong knowledge in cGxP and regulatory compliance.
• Available to work extended hours, including weekends and holidays.

Responsibilities

• Characterize process optimization strategies and troubleshoot operational issues.
• Develop and present interpretations of results for engineering projects.
• Apply engineering principles to major system modifications and experiments.

Skills

Aseptic processing experience

Bilingual (English/Spanish)

MS Windows and Microsoft Office proficiency

Knowledge of cGxP and regulatory guidance

Experience in manufacturing process

Validation protocol knowledge

Education

Masters in Engineering + 2 years experience or Bachelor's + 4 years 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:

Description

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Qualifications

• Engineer with years of experience, preferably in aseptic processing environments, including Fill/Finish operations such as vial and syringe filling lines.
• Experience in characterization activities and performance qualification (PQ) for New Product Introductions (NPI).
• Minimum of 4 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.
• 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).
• Available to work extended hours, possibility of weekends and holidays.

Education

• Masters + 2 years of Engineering experience OR Bachelors in Engineering + 4 years of Engineering experience. Preferred: Mechanical or Chemical Engineering
• Working knowledge of pharmaceutical/biotech processes
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production
• Able to develop solutions to routine technical problems of limited scope
• Comprehensive understanding of validation protocol execution requirements.

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.