Validation & Engineering Group, Inc.

MV02-012926 Validation Specialist

Validation & Engineering Group, Inc.  •  Juana Díaz, PR (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 talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Alcohol System Validation Specialist (CQV – GMP Manufacturing)

We are seeking an experienced Alcohol System Validation Specialist to support the qualification and validation of alcohol storage, distribution, and delivery systems within a GMP-regulated manufacturing operation. This role plays a key part in ensuring systems used for cleaning and sanitization meet regulatory requirements and are fit for intended use.

Key Responsibilities:

• Execute IQ, OQ, and PQ for alcohol systems, including tanks, loops, pumps, and point-of-use connections

• Develop, review, and approve validation protocols, reports, and traceability documentation

• Ensure compliance with GMP, FDA, and internal quality standards

• Support risk assessments, deviations, and change controls related to validated systems

• Partner with Engineering, Quality, and Operations during system installation and modifications

• Support audits and regulatory inspections as a system SME

Qualifications:

• Bachelor’s degree in Engineering, Science, or related field

• Hands-on experience in CQV within regulated manufacturing environments

• Strong knowledge of validation lifecycle and GMP documentation practices

• Experience validating utility or process systems (alcohol systems preferred)

• Strong communication and technical writing skills

Preferred Experience:

• Pharmaceutical, biopharmaceutical, or medical device manufacturing

• Utility systems validation (alcohol loops, WFI, clean steam, compressed gases)

• Risk-based validation approaches

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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