Validation & Engineering Group, Inc.

Principal Engineer

Validation & Engineering Group, Inc.  •  Carolina, PR (Onsite)  •  24 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 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. Utilizes advanced engineering knowledge across multiple disciplines, including process engineering, unit operations, and equipment projects, to support process characterization, optimization, scale-up, manufacturing support, and large-scale engineering initiatives.

Responsibilities

  • Establish engineering policies for major segments of the organization.
  • Interpret, execute, and recommend modifications to company-wide engineering policies and standards.
  • Develop organizational and project budgets encompassing multiple engineering disciplines for large or complex projects.
  • Apply advanced technical principles, theories, and concepts in the development of new engineering methodologies and solutions.
  • Perform work involving in-depth investigation of technical subject areas, definition of project scope, selection of areas of investigation, and development of novel concepts.
  • Conceive plans and conduct engineering research and investigations in areas of considerable scope and complexity.
  • Plan, organize, and coordinate the work of engineers and technical staff.
  • Lead efforts with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation departments to develop requirements and recommendations for large and highly complex system, facility, or process modifications.
  • Serve as a technical engineering resource with expertise across multiple engineering disciplines.
  • Design, execute, implement, and direct engineering and process projects that significantly contribute to achieving strategic and high-priority business goals.
  • Support process characterization, optimization, scale-up, and manufacturing support initiatives.

Qualifications & Skills

  • Doctorate Degree in Engineering with a minimum of 2 years of engineering experience; OR
  • Master’s Degree in Engineering with a minimum of 4 years of engineering experience; OR
  • Bachelor’s Degree in Engineering with a minimum of 6 years of engineering experience.
  • Preferred Qualifications
  • Experience with Clean Utilities.
  • Experience with GMP investigations and deviation documentation.
  • Working knowledge of pharmaceutical and biotechnology manufacturing processes.
  • Familiarity with validation processes and validation protocol execution requirements.
  • Familiarity with documentation practices in highly regulated environments.
  • Ability to interpret and apply GLPs and GMPs.
  • Ability to apply engineering science to manufacturing and production processes.
  • Ability to develop solutions to technical problems through engineering analysis and problem-solving methodologies.
  • Ability to operate specialized laboratory equipment, engineering systems, and computer applications as appropriate.

Technical & Professional Skills

  • Strong engineering problem-solving and analytical skills.
  • Technical report writing experience.
  • Strong verbal and written communication skills.
  • Comprehensive understanding of validation protocol execution requirements.
  • Experience leading multidisciplinary engineering projects and coordinating cross-functional teams.
  • Strong organizational, planning, and project leadership skills.
  • Ability to manage multiple priorities and complex technical initiatives in regulated pharmaceutical or biotechnology environments.
  • Technical Writing skills and investigations processes.
  • Available to work extended hours, possibility of weekends and holidays.

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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