Validation & Engineering Group, Inc.

MV02-021226 Sr Cleaning Validation Specialist

Validation & Engineering Group, Inc.  •  Manatí, PR (Onsite)  •  2 months 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:

  • Senior Cleaning Validation Specialist

Senior Cleaning Validation Specialist to support cleaning validation lifecycle activities within a regulated cGMP manufacturing environment. This role is critical in ensuring equipment cleaning processes meet regulatory and quality compliance standards.

Key Responsibilities

  • Lead cleaning validation lifecycle activities
  • Develop & review protocols and reports
  • Define sampling strategies and risk assessments
  • Establish acceptance criteria (PDE / MACO / HBEL)
  • Support deviations, investigations & change controls
  • Collaborate with Manufacturing, QA, Engineering & Labs
  • Ensure compliance with FDA / EMA / cGMP requirements

Required Qualifications

  • Bachelor’s degree in Science or Engineering.
  • 5+ years of Cleaning Validation experience.
  • Strong knowledge of PDE / MACO calculations.
  • Experience with validation documentation.
  • cGMP pharmaceutical or biotech background.

Preferred Experience

  • Multi-product facilities
  • Biotech / sterile manufacturing
  • CIP / automated cleaning systems
  • HBEL / toxicological risk assessments

Core Skills

  • Technical writing
  • Risk-based decision making
  • Problem-solving & investigations
  • Cross-functional collaboration
  • Compliance-driven mindset
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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