Validation & Engineering Group, Inc.

Validation Engineer

Validation & Engineering Group, Inc.  •  Raleigh, NC (Onsite)  •  2 months ago
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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.

We are seeking a highly motivated Validation Engineer to support validation activities within regulated industries such as Pharmaceuticals, Biotechnology, Medical Devices, Chemicals, or Food Manufacturing The Validation Engineer will ensure equipment, systems, and processes meet regulatory requirements and function reliably to maintain product quality and patient safety.

Key Responsibilities

  • Plan, develop, and execute validation protocols (IQ, OQ, PQ) for equipment, utilities, facilities, and manufacturing systems.
  • Support validation of laboratory instruments, production equipment, cleaning processes, and computerized systems.
  • Ensure compliance with cGMP, FDA, EMA, and other applicable regulatory guidelines
  • Draft and review validation documentation, including protocols, reports, SOPs, and risk assessments.
  • Perform troubleshooting and root cause analysis for validation or equipment-related deviations.
  • Collaborate with cross-functional teams (Engineering, Quality, Manufacturing, Laboratory) to support project deliverables.
  • Participate in change control, CAPA, and continuous improvement initiatives.
  • Maintain accurate records and ensure documentation is audit-ready at all times.

Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • 5+ years of experience in validation within pharmaceutical, biotechnology, or related regulated industry.
  • Hands-on experience with validation of manufacturing equipment, laboratory instruments, and/or computerized systems.
  • Strong knowledge of GMP, GLP, and regulatory guidelines
  • Excellent analytical, organizational, and technical writing skills.
  • Ability to work independently and in cross-functional teams.

Preferred Skills

  • Experience with cleaning validation, sterilization, utilities (HVAC, water, compressed gases)
  • Familiarity with data integrity and 21 CFR Part 11 compliance
  • Knowledge of risk-based validation approaches (e.g., ASTM E2500).

Additional Information

All your information will be kept confidential according to EEO guidelines.

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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