Job Description

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.

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.

FUNCTIONS

General:

1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.

2. Develop engineering policies and procedures that affect multiple organizational units.

3. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.

4. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.

5. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.

6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.

7. Application of mature engineering knowledge in planning and conducting projects.

*Other functions may be assigned

Design Engineering:

1. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.

2. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.

3. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.

4. Coordinate the work of consultants, architects and engineering firms on development of standard design documents.

5. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project

Qualifications

EDUCATION

• Bachelors in Engineering + 4 years of Engineering experience.

Additional Information

• GMP knowledge: Strong background in regulated environments with ability to apply GMP in manufacturing and validation.
• Validation expertise: Experience in drafting, executing, and approving validation.
• Time pressure filling: Hands-on experience with time pressure filling systems.
• Technical documentation: Experience in preparing, reviewing, and approving protocols, reports, and strategy presentations.
• Protocol development: Experienced in designing protocols for complex systems such as filling lines and aseptic processes.
• Communication skills: Strong written and verbal communication in English and Spanish.
• Collaboration: Proven experience working with QA, Manufacturing, and Engineering teams during critical activities.
• Shift flexibility: Willing and able to support non-standard shifts, including nights, weekends, and extended hours.