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Cgmp Consulting Jobs in Puerto Rico (NOW HIRING)

Techengpr

Process Project Manager

Carolina, PR · On-site

$110 - $150/hr

Coordinate multidisciplinary engineering teams, contractors, consultants, and equipment vendors ... Ensure compliance with cGMP requirements, engineering standards, environmental regulations, and ...

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical ... requirements for cGMP operations. * Expertise in generation, storage and distribution of ...

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical ... requirements for cGMP operations. * Expertise in generation, storage and distribution of ...

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical ... requirements for cGMP operations. * Expertise in generation, storage and distribution of ...

Techengpr

CSV C&Q Technical Lead

Carolina, PR · On-site

$120 - $180/hr

Technical & Engineering Consulting LLC is seeking an experienced Automation / CSV C&Q Technical ... Ensure compliance with GAMP 5, Data Integrity (ALCOA+), cGMP, and company quality procedures.

Techengpr

Project Manager

Carolina, PR · On-site

$120 - $180/hr

About the Opportunity Technical & Engineering Consulting LLC is seeking an experienced Electrical ... Ensure compliance with cGMP requirements, OSHA regulations, engineering standards, and company ...

Veg Group

Specialist QA (5:00 pm - 5:30 am)

Juncos, PR · On-site

$70 - $90/hr

... cGMP), Good Laboratory Practices (cGLP), and other applicable regulations. * Ensure that deviations ... consulting level technical proficiency. * Experience with validation of GxP applications, including ...

Pinnaql

Specialist QA (5:00 pm - 5:30 am)

Juncos, PR · On-site

... cGMP), Good Laboratory Practices (cGLP), and other applicable regulations. Ensure that deviations ... consulting level technical proficiency. Experience with validation of GxP applications, including ...

Techengpr

HVAC Systems Utilities Engineer

Carolina, PR · On-site

$80 - $100/hr

Technical & Engineering Consulting is seeking an experienced HVAC Systems Utilities Engineer to ... Ensure compliance with FDA, cGMP, and applicable regulatory requirements. * Support HVAC and ...

Inteldot

Specialist QA 35669

Juncos, PR · On-site

... consulting background technical proficiency. * Possess robust knowledge and experience with ... Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes ...

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Cgmp Consulting information

What is cGMP consulting?

cGMP consulting refers to professional advisory services that help pharmaceutical, biotechnology, and related industries comply with current Good Manufacturing Practices (cGMP) regulations. These consultants provide expertise in regulatory requirements, quality assurance, process improvement, and inspections to ensure that manufacturing processes meet FDA or international standards. cGMP consultants can assist with audits, training, documentation, and remediation to help companies maintain compliance and avoid regulatory issues.

What are the key skills and qualifications needed to thrive as a cGMP consultant?

To excel as a CGMP Consultant, you need a solid background in pharmaceutical or biotech manufacturing, in-depth knowledge of current Good Manufacturing Practices (CGMP), and often a relevant science or engineering degree. Familiarity with regulatory databases, quality management systems (QMS), and certifications like Six Sigma or ASQ-CQA is highly beneficial. Strong analytical thinking, communication, and problem-solving skills help you effectively guide clients through regulatory compliance and process improvements. These skills are vital to ensure product quality, regulatory adherence, and the successful implementation of best practices within client organizations.

What are some common challenges faced by professionals in cGMP consulting, and how can they be addressed?

CGMP consultants often face challenges such as staying current with evolving regulations, managing client expectations, and adapting best practices to diverse manufacturing environments. To address these, consultants must engage in ongoing professional development, maintain strong relationships with regulatory bodies, and develop tailored compliance strategies for each client. Effective communication and proactive problem-solving also help ensure successful project outcomes and build client trust.

What does cGMP Consulting do?

cGMP consulting involves providing expertise to ensure pharmaceutical, biotech, and medical device companies comply with current Good Manufacturing Practices (cGMP) regulations. Consultants assist with quality systems, validation, audits, and regulatory submissions to maintain product safety and compliance standards.

What job categories do people searching Cgmp Consulting jobs in Puerto Rico look for?

The top searched job categories for Cgmp Consulting jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Cgmp Consulting jobs?

Cities in Puerto Rico with the most Cgmp Consulting job openings:

Cgmp Consulting jobs near you

HVAC Systems Utilities Engineer

Technical and Engineering Consulting

Carolina, PR

Full-time

Re-posted 28 days ago

Job description

Overview

Technical & Engineering Consulting is seeking an experienced HVAC Systems Utilities Engineer to support pharmaceutical manufacturing operations and capital projects. The selected candidate will serve as the site subject matter expert (SME) for HVAC systems and provide engineering support for critical utilities including chillers, compressors, cooling towers, air handling units (AHUs), and cleanroom environmental control systems.

This position requires strong technical expertise in GMP-regulated environments, cleanroom HVAC design, qualification, troubleshooting, and project execution.

Key Responsibilities HVAC & Utilities Engineering
  • Serve as the technical lead for HVAC systems supporting manufacturing and cleanroom operations.
  • Perform psychrometric analysis, airflow calculations, and heat load assessments.
  • Support design, operation, and optimization of cleanroom HVAC systems.
  • Manage pressure cascades, air change rates (ACH), airflow strategies, temperature, humidity, and differential pressure controls.
  • Provide technical oversight for AHUs, HEPA/ULPA filtration systems, dampers, humidification systems, and chilled water integration.
  • Support utilities systems including chillers, cooling towers, compressors, and associated distribution networks.
Compliance & Validation
  • Ensure compliance with FDA, cGMP, and applicable regulatory requirements.
  • Support HVAC and utility equipment qualification activities (IQ/OQ/PQ).
  • Participate in requalification, change control, Environmental Monitoring (EM), and Contamination Control Strategy (CCS) programs.
  • Apply industry standards including ISO 14644, EU GMP Annex 1, and ISPE Baseline Guides.
Engineering Projects
  • Develop User Requirements Specifications (URS), Project Charters, and CAPEX business cases.
  • Participate in design reviews and approve P&IDs.
  • Develop and execute FAT and SAT protocols.
  • Support startup, commissioning, qualification, and automation activities.
  • Conduct risk assessments (FMEA) and support continuous improvement initiatives.
  • Develop maintenance strategies, spare parts plans, and job plans.
Operations Support
  • Provide daily technical support to manufacturing and facilities operations.
  • Lead troubleshooting efforts for HVAC and utility-related issues.
  • Conduct root cause investigations and implement corrective actions.
  • Review and interpret TAB reports and filter integrity testing results (DOP/PAO).
  • Define return-to-service requirements following maintenance activities.
  • Develop, review, and update SOPs and operating procedures.
Required Qualifications
  • Bachelor's Degree in Mechanical Engineering, Chemical Engineering, or related engineering discipline.
  • Minimum 5+ years of experience supporting HVAC systems in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
  • Strong knowledge of:
    • Cleanroom HVAC systems
    • Air handling units (AHUs)
    • Chillers, cooling towers, and compressors
    • Building Management Systems (BMS)
    • HVAC qualification and validation
    • cGMP and regulatory requirements
  • Experience with P&IDs, engineering documentation, and project execution.
  • Demonstrated troubleshooting and root cause analysis skills.
Preferred Qualifications
  • Knowledge of ISO 14644 and EU GMP Annex 1 requirements.
  • Experience with FAT/SAT, commissioning, and startup activities.
  • ASHRAE certification.
  • LEED certification.
  • ISPE pharmaceutical engineering training or certification.
Desired Skills
  • Strong technical leadership and communication skills.
  • Ability to work independently and cross-functionally.
  • Excellent problem-solving and analytical capabilities.
  • Experience managing multiple priorities in a fast-paced manufacturing environment.
Work Environment

This position supports pharmaceutical manufacturing and utilities operations and may require field work, equipment walkdowns, troubleshooting activities, and support during project startup and qualification phases.

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