Sr Engineer

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

Benefits offered by this job

Dietary allowances

Job summary

Validation & Engineering Group, Inc. seeks a Sr Engineer to independently characterize and optimize processes in manufacturing, pilot plants or capital projects. You will develop, organize and present analyses for complex engineering issues and lead system modifications.

Ideal candidates have aseptic experience, PQ/NPI exposure, and strong regulatory knowledge, with fluency in English and Spanish. Occasional extended hours may be required in a regulated environment.

Qualifications

• Engineer with aseptic processing experience including Fill/Finish lines.
• Experience in characterization activities and PQ for NPI.
• Experience in pharmaceutical/medical device/biotech industries.
• Experience in direct process/manufacturing areas.
• Bilingual in English and Spanish with strong communication skills.
• Proficient with Windows and MS Office.
• Knowledge of cGxP and regulatory guidance for compliance.
• Experience in design documentation (URS, DS), IQ, OQ, PQ protocols and deviations.
• Understand SDLC, risk assessment, data integrity, FAT/SAT.
• Available for extended hours including weekends/holidays.

Responsibilities

• Characterize process optimization strategies and troubleshoot operations.
• Design and implement major system modifications and capital projects.
• Analyze and present results for complex engineering issues.

Skills

Aseptic processing

Fill/Finish

Characterization

NPI PQ

Process/manufacturing

Bilingual English/Spanish

MS Office

cGxP/compliance

URS/DS/IQ/OQ/PQ

SDLC/Risk Assessment

Data Integrity

FAT/SAT

GLPs/GMPs

Lab equipment operation

Education

Masters + 2 years engineering experience

Bachelors in Engineering + 4 years

Preferred: Mechanical or Chemical Engineering

Tools

MS Windows

Microsoft Office

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:

• Sr Engineer

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

Competencies/Skills:

• 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.