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 - Biotechnology Packaging (Vials, Syringes, SureClick)

Job Summary:

We are seeking a highly skilled and experienced Senior Engineer to lead the development and optimization of packaging systems for biotechnology products, including vials, syringes, and SureClick auto-injectors. The ideal candidate will bring extensive expertise in primary and secondary packaging design, development, testing, and validation, ensuring compliance with regulatory standards while driving innovation and sustainability.

Key Responsibilities:

• Packaging Development:

• Design, develop, and validate innovative packaging solutions for biotechnology products, including vials, prefilled syringes, and SureClick auto-injectors.

• Lead packaging component selection, material compatibility studies, and design optimization for functionality and patient ease-of-use.

• Regulatory Compliance:

• Ensure all packaging solutions meet global regulatory requirements (e.g., FDA, EMA, ISO).

• Author and review technical documentation, including design protocols, reports, and regulatory submissions.

• Testing and Validation:

• Oversee packaging testing processes, including container closure integrity, extractables and leachables, and mechanical performance.

• Lead design verification and validation activities to support product launch and lifecycle management.

• Cross-functional Collaboration:

• Partner with R&D, manufacturing, quality, and supply chain teams to ensure seamless integration of packaging systems into production processes.

• Work with external suppliers and contractors to source and qualify packaging materials and components.

• Innovation and Sustainability:

• Stay updated on the latest packaging technologies and trends in biotechnology and pharmaceuticals.

• Drive initiatives to improve sustainability, reduce costs, and enhance patient-centric design.

Qualifications:

• Education:

• Bachelor’s or Master’s degree in Engineering (e.g., Mechanical, Biomedical, Chemical, Packaging) or a related field.

• Experience:

• Minimum 8-10 years of experience in packaging engineering within the biotechnology, pharmaceutical, or medical device industries.

• Proven expertise with vials, prefilled syringes, and auto-injector devices such as SureClick.

• Technical Skills:

• Strong knowledge of packaging design, material science, and manufacturing processes.

• Familiarity with industry standards (e.g., ASTM, USP, ISO) and regulatory guidelines for packaging.

• Experience with Computer-Aided Design (CAD) and packaging simulation tools.

• Soft Skills:

• Excellent problem-solving and analytical abilities.

• Strong project management and leadership skills.

• Effective communication and ability to work in cross-functional teams.

Preferred Skills:

• Hands-on experience with cold-chain packaging for biologics.

• Knowledge of serialization and track-and-trace requirements.

• Familiarity with automation and robotics in packaging processes.

Work Environment:

• Full-time position with occasional travel to manufacturing sites and suppliers.

• Collaborative and dynamic work environment in a biotechnology-focused organization.