Validation & Engineering Group, Inc.

CQV Specialist

Validation & Engineering Group, Inc.  •  Carolina, PR (Hybrid)  •  9 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 ethical standards for the following position:

  • CQV Specialist



We are seeking a CQV Specialist to support commissioning, qualification, and validation activities for sterile liquid pharmaceutical manufacturing and packaging equipment and systems. The role will primarily support packaging and solution preparation systems, while also assisting with related validation activities for equipment, utilities, facilities and manufacturing processes as needed.

This position is ideal for a motivated, hands-on professional who can support protocol development and field execution activities in a GMP-regulated manufacturing environment while working closely with an experienced validation team.

Responsibilities:

  • Support commissioning, qualification, and validation activities for packaging equipment, including fillers, cappers, labelers, conveyors, vision systems, and related process equipment.
  • Assist with qualification activities for solution preparation systems, utilities, facilities and supporting manufacturing systems as needed.
  • Develop, execute, and support validation documentation, including risk assessments, FAT/SAT protocols, IQ/OQ/PQ protocols, and summary reports.
  • Provide hands-on support during protocol execution and field verification activities.
  • Support troubleshooting efforts, deviation resolution, and documentation updates during validation execution.
  • Work closely with engineering, manufacturing, quality, and validation teams to support project timelines and execution priorities.
  • Ensure validation deliverables comply with cGMP requirements, FDA expectations, and internal procedures.

Qualifications:

  • Bachelor’s degree in Engineering, Biology, Chemistry, Microbiology, or other related Natural Science discipline.
  • At least 3–5 years of CQV experience within a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
  • Experience supporting IQ/OQ/PQ protocol development and execution activities.
  • Packaging equipment validation experience preferred; however, strong equipment CQV experience will also be considered.
  • Experience with Kneat or electronic validation systems preferred.
  • Working knowledge of cGMP regulations and validation lifecycle practices.
  • Strong organizational, communication, and technical writing skills.
  • Ability and willingness to work fully on-site in a fast-paced manufacturing environment. This position does not offer remote or hybrid work options, and candidates must be willing to support activities at client site locations as required.

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.

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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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