Sr Engineer

Pinnaql; Carolina (PR); On-site; USD 100,000 - 140,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks an experienced engineer to independently drive process optimization and troubleshooting in pharma manufacturing environments.

You will apply advanced engineering principles to design and implement major system modifications and capital projects, while compiling results for operation teams and regulatory bodies. Ideal candidates have 4+ years in pharma/biotech, aseptic experience preferred, and strong knowledge of cGxP, documentation, and validation

Qualifications

• Engineering degree with pharma/biotech exposure required.
• Bilingual English/Spanish with strong communication skills.
• Experience in validation, PQ/IQ/OQ/PQ protocol development.
• Familiarity with cGxP regulations and GMP environments.

Responsibilities

• Characterize and lead process optimization strategies in manufacturing or capital projects.
• Develop and execute validation plans (IQ/OQ/PQ) and related reports.
• Analyze results, present interpretations, and support regulatory compliance.

Skills

Bilingual EN/ES

Regulatory knowledge

Analytical skills

Project management

SOPs and documentation

Education

Master's in Engineering

Bachelor's in Engineering

Tools

MS Office

Windows

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.