Validation & Engineering Group, Inc.

MV02-031626 Principal Engineer

Validation & Engineering Group, Inc.  •  Carolina, PR (Onsite)  •  20 days ago
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Job Description

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

  • Principal Engineer



Manages and/or applies extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems facilities or processes. Employs an extensive technical knowledge of more than one area of engineering (process, unit operations, and equipment project) in complex process characterization, optimization, scale-up, or manufacturing support projects.

Functions:

1. Establish engineering policies for a major segment of the company.

2. Interpret, execute, and recommend modifications to company-wide policies.

3. Develop organizational budgets or project budgets encompassing all disciplines for large or complex project.

4. Apply advanced technical principles, theories, and concepts in the development of new principles and concepts.

5. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept.

6. Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity.

7. Plan, organize and coordinate work of a staff of engineers and/or technicians.

8. Lead efforts 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 or process modifications.

9. Established a corporate Engineering resource, specializing in more than one area of engineering.

10. Designs, executes, implements and directs engineering or process projects which significantly contribute to attaining high priority goals.** Other functions may be assigned.

Education:

  • Bachelors in Engineering + 6 years of Engineering experience.


Preferred Qualifications:

  • Experience Working with Clean Utilities Systems such as Distilled Water, Purified Water, RO System.
  • Experience working on Clean Gases [Process Air, GMP gases supply like Oxygen, Nitrogen].
  • Experience documenting and managing Deviation [non-conformance]
  • Proficient in GMP documentation and the process improvement of SOP documents.
  • Ability to work on Critical Operation and Capital project environment.
  • Working knowledge of pharmaceutical/biotech processes
  • Familiarity with validation processes
  • Familiarity with documentation in a highly regulated environment
  • Ability to operate specialized laboratory equipment and computers as appropriate.
  • Ability to interpret and apply GLPs and GMPs.
  • Ability to apply engineering science to production.
  • Able to develop solutions to routine technical problems of limited scope
  • Comprehensive understanding of validation protocol execution requirements.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Validation & Engineering Group, Inc.

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Proudly serving our clients since 1997.

Our Mission states in part: "provide our clients with the best resources to meet their needs". In our search for the best talent, we are inclusive and do not discriminate. V&EG is proud to be an equal opportunity workplace and is an affirmative action employer.

Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.

Our agility in responding to our clients’ needs, access to the best pool of talent, and the combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries.

At Validation & Engineering Group we provide professional expertise in the areas of:

•Audit and Assessment

•Automated Process Control System Qualification

•Equipment and Facilities Qualification

•Facilities Start-Up and Commissioning

•GAP Analysis

•Information Systems Computer Validation

•Packaging and Process Analysis

•Process & Cleaning Validation

•Project Management

•Quality Systems

•Risk Based Approach

•Regulatory Compliance

•Standard Operating and Maintenance Procedures

•Training

•Utilities Support and Qualification

In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical.

Our Offices:

Puerto Rico:

Centro Internacional de Mercadeo I 100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico

Phone: (787) 622-0996

United States:

2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States

Phone: (770) 403-5802

Industry
Architecture & Engineering
Company Size
51-200 employees
Headquarters
Guaynabo, PR
Year Founded
1997
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