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:
This position supports equipment design and process implementation activities under the guidance of the Staff Engineer. The Senior Engineer leads the design, development, validation, and integration of manufacturing equipment, ensuring full alignment with project requirements, regulatory standards, and operational excellence in a GMP-regulated environment.
The role demands deep technical expertise across the full validation lifecycle — including URS development, FAT/SAT execution, and Computer System Validation (CSV) — as well as hands-on experience with PLC systems and controls integration. The candidate will drive end-to-end project implementation: from equipment design and installation through startup, commissioning, and qualification.
This position requires the ability to work independently while partnering with cross-functional teams (Engineering, Quality, Operations) and external vendors, with willingness to travel domestically and internationally up to 25% (Philadelphia, Rhode Island, Germany, Japan).
Key Responsibilities:
- Develop User Requirement Specifications (URS) and mechanical/electrical designs for assembly and packaging equipment.
- Lead full validation lifecycle activities: FAT, SAT, CSV, equipment integration, and startup.
- Drive process design for new equipment and ensure product design requirements are met.
- Execute commissioning and qualification activities for new and existing equipment.
- Provide technical oversight to ensure equipment meets safety, regulatory, and operational standards.
- Manage suppliers and external vendors on capital projects, controlling scope, cost, and lead time.
- Collaborate with Procurement and Legal on vendor contracts.
- Develop detailed 3D models and 2D drawings using CAD tools (AutoCAD, SolidWorks).
- Create and maintain engineering documentation (URS, assembly instructions, bill of process, etc.).
- Optimize equipment design for manufacturability, cost reduction, maintainability, and efficiency.
- Lead design reviews, risk assessments, and FMEA to ensure reliability and performance.
- Perform engineering analyses (stress, strain, thermal, fluid dynamics) to validate designs.
- Ensure seamless integration of mechanical systems with electrical, controls, and maintenance teams.
- Support PLC systems and controls integration as part of equipment implementation.
- Execute capital projects in GMP manufacturing environments.
- Ensure compliance with all safety regulations and quality policies, procedures, and GMP standards.
- Apply statistical analysis and SPC systems to support data-driven decision-making.
- Manage multiple priorities and maintain equipment qualification schedules.
Qualifications:
- Bachelor's degree in Mechanical, Electrical, Chemical, or Industrial Engineering (Master's preferred).
- Minimum 8 years of engineering experience in pharmaceutical and/or medical device industries.
- Demonstrated experience across the full validation lifecycle (URS, FAT, SAT, CSV).
- Experience with PLC programming and controls integration.
- Proven track record supporting full project implementation: design, installation, startup, commissioning, and qualification.
- Strong experience executing capital projects within GMP-regulated manufacturing environments.
- Proficiency in AutoCAD and/or SolidWorks.
- Strong analytical and problem-solving skills, including FMEA and statistical analysis/SPC.
- Familiarity with GMP, ISO standards, Lean Manufacturing, and FDA-regulated environments.
- Ability to work independently and lead solutions under general direction.
- Strong project management, organization, and communication skills.
- Willingness and ability to travel domestically and internationally up to 25%.
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.
