Sr. C&Q Specialist
Juncos, PR · On-site
More than five years of experience in Equipment and Computer System Validation within pharmaceutical facilities. * Experience with digital validation solutions (e.g., ALM or equivalent systems)
Sr. C&Q Specialist
Juncos, PR · On-site
More than five years of experience in Equipment and Computer System Validation within pharmaceutical facilities. * Experience with digital validation solutions (e.g., ALM or equivalent systems)
Water System Validation Specialist & Equipment Qualification
Vega Baja, PR · On-site
$60 - $80/hr
... validation and engineering documentation in the FDA-regulated industry ... Ideal candidates should have a Bachelor's degree in a technical field, experience in pharmaceutical ...
Water System Validation Specialist & Equipment Qualification
Vega Baja, PR · On-site
$60 - $80/hr
... validation and engineering documentation in the FDA-regulated industry ... Ideal candidates should have a Bachelor's degree in a technical field, experience in pharmaceutical ...
JT678 - QUALITY APPLICATIONS SPECIALISTS
Villalba, PR · On-site
$125 - $150/hr
QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and ... Computer and software validation CSV * SOP Development * Change control of Medical Devices * 1st ...
JT678 - QUALITY APPLICATIONS SPECIALISTS
Villalba, PR · On-site
$125 - $150/hr
QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and ... Computer and software validation CSV * SOP Development * Change control of Medical Devices * 1st ...
Validation Specialist
Aibonito, PR · On-site
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Specialist
Aibonito, PR · On-site
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
QA Specialist- ProQN669
Juncos, PR · On-site
$60 - $80/hr
Experience with computer systems validation (CSV) or computer systems quality assurance (CSA/CSQA), particularly within regulated environments. * Experience supporting medical device environments and ...
QA Specialist- ProQN669
Juncos, PR · On-site
$60 - $80/hr
Experience with computer systems validation (CSV) or computer systems quality assurance (CSA/CSQA), particularly within regulated environments. * Experience supporting medical device environments and ...
Validation Analyst
Anasco, PR · On-site
$30 - $31/hr
... computer and automation systems. Plans, coordinates, and participates in a compliant validation ... Minimum of four (4) years of experience in the medical device and/or pharmaceutical manufacturing ...
Quick apply
Validation Analyst
Anasco, PR · On-site
$30 - $31/hr
... computer and automation systems. Plans, coordinates, and participates in a compliant validation ... Minimum of four (4) years of experience in the medical device and/or pharmaceutical manufacturing ...
Validation Engineer
Barceloneta, PR · On-site
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Engineer
Barceloneta, PR · On-site
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
More than five years of experience in Equipment and Computer System Validation within pharmaceutical facilities. * Experience with digital validation solutions (e.g., ALM or equivalent systems)
More than five years of experience in Equipment and Computer System Validation within pharmaceutical facilities. * Experience with digital validation solutions (e.g., ALM or equivalent systems)
CQV Specialist Utilities
Juncos, PR · On-site
$100 - $125/hr
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
CQV Specialist Utilities
Juncos, PR · On-site
$100 - $125/hr
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Engineer - Upstream
Manati, PR · On-site
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Engineer - Upstream
Manati, PR · On-site
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Engineer - 35631
Juncos, PR · On-site
mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other ...
Engineer - 35631
Juncos, PR · On-site
mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other ...
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Specialist
Aibonito, PR · On-site
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Specialist
Aibonito, PR · On-site
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Specialist
Aibonito, PR · On-site
$100 - $125/hr
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Specialist
Aibonito, PR · On-site
$100 - $125/hr
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Engineer - Upstream
Juncos, PR · On-site
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Engineer - Upstream
Juncos, PR · On-site
... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
JT664 - MANUFACTURING ENGINEER II
Humacao, PR · On-site
$73K - $95K/yr
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and ... Process/Computer System Validation * CAD Electrical Design proficiency * PLC/HMI/Vision Programing
JT664 - MANUFACTURING ENGINEER II
Humacao, PR · On-site
$73K - $95K/yr
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and ... Process/Computer System Validation * CAD Electrical Design proficiency * PLC/HMI/Vision Programing
Computer System Validation Csv Pharmaceutical information
What is computer system validation (CSV) in the pharmaceutical industry?
Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.
What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?
CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.
What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?
To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.
What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?
| Aspect | Computer System Validation Csv Pharmaceutical | Quality Assurance Specialist |
|---|---|---|
| Certifications | GxP, 21 CFR Part 11, Validation certifications | GxP, ISO, QA certifications |
| Work Environment | Pharmaceutical manufacturing, regulated labs | Quality departments across industries, including pharma |
| Employer & Industry | Pharmaceutical companies, biotech firms | Pharma, biotech, healthcare organizations |
| Primary Focus | Ensuring computer systems meet validation and compliance standards | Maintaining quality standards and process improvements |
Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.
What are popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Puerto Rico?
For Computer System Validation Csv Pharmaceutical jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Puerto Rico look for?
The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Computer System Validation Csv Pharmaceutical jobs?
Cities in Puerto Rico with the most Computer System Validation Csv Pharmaceutical job openings:
Job description
Mentor Technical Group (MTG) provides specialized technical support and solutions for FDA-regulated industries. MTG is recognized for its expertise in life sciences engineering, ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy standards. Resources considered for this RFP will support pharmaceutical manufacturing operations and must meet the following minimum qualifications.
Responsibilities
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Responsibilities
- Support Commissioning and Qualification (C&Q) activities for plants and equipment.
- Develop, review, and maintain commissioning and qualification procedures and documentation.
- Write, review, and approve C&Q protocols and reports for various systems, including HVAC, utilities, production equipment, and laboratory equipment.
- Execute commissioning and qualification activities and coordinate with internal teams and external consultants to ensure timely delivery.
- Manage change controls and deviations related to plants and equipment.
- Support maintenance and calibration functions to improve compliance and quality.
- Provide expertise in troubleshooting and root cause investigations.
- Facilitate the transfer of technical knowledge across units and sites.
- Proven background in pharmaceutical product manufacturing, specifically in sterile packaging operations.
- Demonstrated experience in Commissioning and Qualification (C&Q) activities.
- Strong knowledge of current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.
- More than five years of experience in Equipment and Computer System Validation within pharmaceutical facilities.
- Experience with digital validation solutions (e.g., ALM or equivalent systems).
- Excellent skills in writing validation, commissioning, and technical documentation in English.
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint, etc.).
- Bilingual proficiency in English and Spanish.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
About Mentor Technical Group
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