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 contributes to the design, development, validation, and integration of manufacturing equipment, ensuring alignment with project requirements, regulatory standards, and operational excellence in a GMP-regulated environment.
The role requires strong technical expertise across the full validation lifecycle, including URS development, FAT/SAT execution, and Computer System Validation (CSV), as well as experience with PLC systems and controls integration. The candidate will play a key role in full project implementation, including equipment design, installation, startup, commissioning, and qualification activities.
This position requires the ability to work independently while collaborating with cross-functional teams (Engineering, Quality, Operations) and external vendors. The role also requires willingness and ability to travel domestically and internationally (up to 25%), including locations such as Philadelphia, Rhode Island, Germany, and Japan.
Key Responsibilities:
- Assist in the development of User Requirement Specifications (URS) and mechanical/electrical designs for assembly and packaging equipment.
- Support full validation lifecycle activities, including FAT, SAT, CSV, equipment integration, and startup.
- Contribute to process design for new equipment and ensure product design requirements are met.
- Participate in commissioning and qualification activities for new and existing equipment.
- Provide technical feedback to ensure equipment meets safety, regulatory, and operational standards.
- Support suppliers and external vendors for capital projects, managing scope, cost, and lead time.
- Collaborate with Procurement and Legal on vendor contracts.
- Develop or obtain 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.
- Participate in design reviews, risk assessments, and FMEA to ensure reliability and performance.
- Collaborate with manufacturing teams to prototype, test, and refine mechanical systems.
- 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 and support capital projects in GMP manufacturing environments.
- Ensure compliance with all safety regulations and BD quality policies, procedures, and GMP standards.
- Support statistical analysis, SPC systems, and data-driven decision-making.
- Manage multiple priorities and maintain equipment qualification schedules.
- Perform other duties as assigned.
Qualifications:
- Bachelor's degree in Mechanical, Electrical, Chemical, or Industrial Engineering (Master's preferred).
- Minimum of 8+ years of engineering experience in pharmaceutical and/or medical device industries.
- Demonstrated experience across the validation lifecycle (URS, FAT, SAT, CSV).
- Experience with PLC programming and controls integration.
- Proven experience supporting full project implementation, including equipment design, installation, startup, commissioning, and qualification.
- Strong experience working on capital projects within GMP-regulated manufacturing environments.
- Experience with cross-functional collaboration (Engineering, Quality, Operations).
- Proficiency in AutoCAD and/or SolidWorks preferred.
- Strong technical, analytical, and problem-solving skills (including FMEA and statistical analysis/SPC).
- Experience with GMP, ISO standards, Lean Manufacturing, and FDA-regulated environments.
- Ability to work independently and determine solutions under general direction.
- Strong project management, organization, and planning skills.
- Excellent communication and interpersonal skills.
- Willingness and ability to travel domestically and internationally (up to 25%).
Principal Requirements:
- Ability to use a computer for extended periods (up to 8 hours).
- Ability to sit for extended periods during meetings (virtual and on-site).
- Ability to stand for extended periods during FAT, SAT, troubleshooting, and on-site activities.
- Ability to climb, squat, and perform physical tasks as needed.
- Ability to work independently in a high-volume manufacturing environment.
- Compliance with all safety and GMP requirements (PPE such as safety shoes, glasses, hair/beard nets, masks, hard hats, etc., as required).
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.
