LL03-251008 Senior Engineer

Validation & Engineering Group, Inc. (V&EG) 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:

• Senior Engineer

This position supports equipment design and process implementation activities under the guidance of the Staff Engineer. The Senior Engineer will contribute to the design, development, and integration of manufacturing equipment, ensuring alignment with project requirements and operational standards. The role requires strong technical skills, hands-on experience, and the ability to work independently on assigned tasks while collaborating with cross-functional teams and external vendors.

Responsibilities:

• Assist in developing User Requirement Specifications (URS) and mechanical/electrical designs for assembly and packaging equipment.
• Support the integration of new equipment through SAT completion, Equipment Integration during install, FAT and startup. Support Process Design on new equipment and ensure product designs are being met.?
• Provide feedback and validate that the equipment design meets safety and operational standards based on experience and validation from respective stakeholders.
• Support suppliers and external design teams (vendor) for larger capital projects?to manage cost, lead time and scope.
• Responsible for vendor contracts?in collaboration with procurement and legal?.
• Create, or obtain from the vendor, detailed 3D models/2D drawings of mechanical components and assemblies using CAD software.
• Create and maintain design documentation, including user requirement specifications, assembly instructions, bill of process, etc. ?
• Support equipment designs to minimize production costs and changeover time, simplify assembly processes, design from the operator's standpoint, maintainability, and ensure manufacturability.?
• Participate in equipment design reviews, risk assessments, and continue to build failure mode and effects analysis (FMEA) to ensure reliability, safety, performance of mechanical systems/equipment.?
• Collaborates with manufacturing teams to build and test prototypes of mechanical systems and components, gathering feedback, iterating on design as necessary.
• Support various engineering analyses / simulation (i.e. stress, strain, thermal, fluid dynamics) to validate and optimize design.
• Work closely with other engineering fields and Maintenance teams. (i.e. electrical/mechanical engineers) to ensure seamless integration of mechanical systems with other project components.
• Comply with all local, state, federal, and BD safety regulations, policies, and procedures.
• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Other duties as assigned.

Minimum Experience:

• Bachelor's degree in Mechanical, Electrical, Chemical, or Industrial Engineering (Master's preferred).
• 8+ years of engineering experience in pharmaceutical/medical devices industry
• Works under general direction. Independently determines and develops approach to solutions.
• Tooling design experience of complex mechanical systems is preferred.
• Experience with PLC programming and Controls.
• Proficiency in Autocad and/or SolidWorks is desired.
• Excellent technical skills including project management, organization, and planning.
• Demonstrated ability to apply problem solving and data analysis methods.
• Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts desired.
• Experience in an FDA regulated quality environment desired.
• Willingness and ability to travel domestically and internationally up to 25% average annually.
• Strong communication skills
• Risk analysis / FMEA
• Statistical analysis / SPC system
• Ability to manage multiple conflicting priorities, and to develop and maintain tool qualification schedules.

Physical requirement:

• Ability to use a laptop/computer for extended periods of time (up to 8 hours)
• Ability to sit for long periods of time (up to 8 hours) in virtual and/or on-site meetings
• Ability to stand for long periods of time (up to 8 hours) when conducting FAT, SAT, on-site equipment/process troubleshooting, etc.
• Ability to climb steps, squat, etc.
• Ability to work independently in High Volume manufacturing floor
• Follow Safety and Quality/GMP requirements for medical device manufacturing site (Safety shoes, safety glasses, hair net, beard net, face mask, hard hat, etc….as required per manufacturing site)