MV01-081225 Sr 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:

• Sr Engineer
• 1st shift, but it will be required to work 2nd or 3rd shift during the CIP Cycle development activities. December shutdown support will be required as well.

PREFERRED:

• Experience in Pharmaceutical or biotechnology industry equipment Commissioning and qualification, installation qualifications.
• Experience in CIP and SIP cycle development.
• Experience developing project plans and strategies.
• Organized, multitasking and ability to work on high pace environment.
• MAXIMO

SUMMARY

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

EDUCATION

• Masters + 2 years of Engineering experience OR
• Bachelors in Engineering + 4 years of Engineering experience.

COMPETENCIES/SKILLS

1. Working knowledge of pharmaceutical/biotech processes

2. Familiarity with validation processes

3. Familiarity with documentation in a highly regulated environment

4. Ability to operate specialized laboratory equipment and computers as appropriate.

5. Ability to interpret and apply GLPs and GMPs.

6. Ability to apply engineering science to production.

7. Able to develop solutions to routine technical problems of limited scope

Demonstrated skills in the following areas:

• Problem solving and applied engineering.
• Basic technical report writing
• Verbal communication
• Comprehensive understanding of validation protocol execution requirements.