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.
Skills Required
- Minimum 4 years experience in pharmaceutical, medical device, or biotechnology industries
- Masters + 2 years engineering experience OR Bachelors in Engineering + 4 years engineering experience
- Experience in characterization activities and performance qualification (PQ) for New Product Introductions (NPI)
- Experience in direct process / manufacturing areas (including Fill/Finish operations)
- Experience in aseptic processing environments, including vial and syringe filling lines
- Must be fully bilingual (English/Spanish) with excellent oral skills
- Proficient using MS Windows and Microsoft Office applications
- Strong knowledge of cGxP and regulatory guidance and how they apply to compliance
- Experience with design documentation (URS, DS), IQ, OQ, PQ protocol development and execution, deviations and report generation
- Familiarity with SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
- Ability to interpret and apply GLPs and GMPs and work in a highly regulated documentation environment
- Available to work extended hours, including possible weekends and holidays
- Preferred degree: Mechanical or Chemical Engineering
What We Do
Pinnaql, Inc. is a professional services consulting firm providing quality, regulatory, and operational excellence solutions to biopharmaceutical, medical device, and CDMO companies worldwide. The company specializes in laboratory validation, engineering, and compliance, helping regulated life sciences organizations navigate manufacturing challenges, reduce execution risks, and accelerate the transition from lab innovation to commercial market readiness.
