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:
• Engineer

Summary:

Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity

Functions:
• Provide solutions to a variety of technical... problems of moderate scope and complexity.
• Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables. (*)
• Initiate and complete routine technical tasks.

Operations Engineering:
• Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
• Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.

Design Engineering:
• Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
• Work with consultants, architects and engineering firms on development of standard design documents.
• Obtain and critique quotes for equipment modifications or installations.
• Generate rudimentary project cost estimates and schedules.
• Other functions may be assigned.

Education
• Master's degree OR Bachelor's degree in Engineering & 2 years of Engineering experience.

Preferred qualifications:
• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes.
• Familiarity with documentation in a highly regulated environment.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Technical Writing.
• Experience in biopharmaceutical industry.
• Knowledge in protein purification
• Statistics (probability, process capability, ect)
• Filtration systems
• Knowledge is systems such as trackwise, PI, SIMCA.
• Available to work extended hours, possibility of weekends and holidays
Juncos Puerto Rico

Salary Criteria