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Cgmp Consulting Jobs in Puerto Rico (NOW HIRING)

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and ... Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ...

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and ... Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ...

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and ... Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ...

Quality Consulting Group

JT908 - MACHINIST I

Aibonito, PR · On-site

$20.75 - $28.25/hr

Conocimiento de entrenamientos y requisitos relacionados con cGMP. * Disponibilidad para Turnos: 6am-6pm Sabado y Domingo con 2 días en turno 10:00pm a 6:00am en la semana. Quality Consulting Group ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer ... cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system ...

MMR Consulting

PR · On-site

MMR Consulting has offices in Canada, USA, and Australia. This is an outstanding opportunity to ... cGMP operation. * Previous PM capital projects experience is required. * Previous Greenfield ...

Mirus Consulting Group

Sr Engineer - 35570

Juncos, PR · On-site

$101K - $139K/yr

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer ... Ensure compliance with cGMP, quality standards, and applicable regulatory requirements. * Generate ...

MMR Consulting

PR · On-site

MMR Consulting has offices in Canada, USA, and Australia. This is an outstanding opportunity to ... cGMP operation. * Previous PM capital projects experience is required. * Previous Greenfield ...

MMR Consulting

PR

MMR Consulting has offices in Canada, USA, and Australia. This is an outstanding opportunity to ... cGMP operation. * Previous PM capital projects experience is required. * Previous Greenfield ...

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Cgmp Consulting information

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 does a consulting position do?

A consulting position involves providing expert advice and solutions to organizations to improve their processes, compliance, or performance. Consultants analyze client needs, develop strategies, and often use industry tools or standards, such as regulatory guidelines, to support their recommendations. The role typically requires strong communication skills and relevant industry knowledge.

How is cGMP different from GMP?

cGMP (current Good Manufacturing Practice) refers to the most up-to-date standards that companies like those in cGMP consulting must follow to ensure product quality and safety, incorporating the latest regulations and technological advancements. GMP (Good Manufacturing Practice) represents the general principles for manufacturing practices that have been established over time. The key difference is that cGMP emphasizes current standards and continuous compliance, requiring professionals to stay informed about evolving regulations and industry best practices.

What is the role of cGMP?

In cGMP consulting, the role involves ensuring that manufacturing processes comply with current Good Manufacturing Practices (cGMP) regulations to guarantee product quality and safety. Professionals in this field often assist companies with regulatory compliance, quality systems, and documentation to meet industry standards and avoid violations.

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, and why are they important?

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.
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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
PHARMACEUTICAL - SR. CQV Manager/PM

PHARMACEUTICAL - SR. CQV Manager/PM

MMR Consulting

PR • On-site

Other

Posted 5 days ago

Job description

Previous Pharmaceutical/Biotech experience is mandatory for this role
(Commissioning, Qualification & Validation - Pharmaceutical Manufacturing)
The work will require 90% travel to work in Denver/Boulder, Raleigh, midwest, Philadelphia, Portland, Chicago or other locations.
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.
MMR Consulting has offices in Canada, USA, and Australia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
This role is for Sr. CQV Manager/PM will require to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives. This individual will oversee cross-functional CQV execution for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes while ensuring compliance with FDA, cGMP, and global regulatory standards.
The ideal candidate will possess strong pharmaceutical project leadership experience within biotech, sterile manufacturing, fill-finish, API, or biologics environments and will serve as a key liaison between engineering, quality, validation, manufacturing, and external vendors. This role requires the ability to manage project schedules, budgets, risks, resources, and validation deliverables in support of facility expansions, new product introductions, and operational readiness initiatives.
Key Responsibilities
  • Lead all CQV project activities for pharmaceutical and biotech manufacturing projects.
  • Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation.
  • Coordinate commissioning and qualification activities for:
    • Process equipment
    • Clean utilities
    • HVAC systems
    • Automation and control systems
    • Manufacturing and packaging lines
  • Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards.
  • Oversee execution of:
    • FAT/SAT protocols
    • IQ/OQ/PQ protocols
    • Validation documentation
    • Deviations and CAPAs
    • Change controls
  • Collaborate with Quality Assurance, Engineering, Manufacturing, Automation, and Regulatory teams to support project milestones and inspection readiness.
  • Manage third-party CQV consultants, contractors, and vendors.
  • Provide risk assessments and mitigation strategies to maintain project timelines and compliance objectives.
  • Support startup, operational readiness, and technology transfer activities.
  • Present project status updates and KPI reporting to senior leadership and stakeholders.

Required Experience
  • Minimum 8-12 years of experience in pharmaceutical, biotech, or life sciences industries.
  • Minimum 5 years of direct CQV project management experience within GMP-regulated manufacturing environments.
  • Proven experience managing large-scale capital projects, facility expansions, or greenfield startup projects.
  • Strong experience with commissioning and qualification of:
    • Cleanrooms
    • Process equipment
    • Utilities
    • Automation systems
    • Manufacturing processes
  • Experience authoring and reviewing validation lifecycle documentation.
  • Demonstrated success leading cross-functional teams and managing multiple project workstreams simultaneously.
  • Experience supporting FDA audits and regulatory inspections.
  • Background in biologics, sterile fill-finish, vaccine, API, or aseptic manufacturing environments strongly preferred.

Required Qualifications
  • Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
  • Strong understanding of:
    • cGMP regulations
    • FDA validation requirements
    • ISPE Baseline Guides (inc. C&Q) and ASTM E2500 GUIDE
    • GAMP 5 principles
  • Proficiency with project management methodologies, scheduling tools, and reporting systems.
  • Excellent communication, leadership, and stakeholder management skills.
  • Ability to work effectively in fast-paced, highly regulated project environments.

Preferred Qualifications
  • Digital Validation software experience (i.e. Kneat or equivalent)
  • PMP certification preferred.
  • Experience with DeltaV, MES, SCADA, or other pharmaceutical automation platforms.
  • Familiarity with Kneat, TrackWise, Veeva, or electronic validation systems.
  • Previous consulting or EPCM experience is a plus.
  • Lean Six Sigma certification preferred.

Compensation: 120,000$ - 150,000$ based on experience.
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

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