Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Alert senior management of quality, compliance, supply, and safety risks. Provide support and ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Alert senior management of quality, compliance, supply, and safety risks. Provide support and ...
QA Specialist- ProQN669
Juncos, PR · On-site
$60 - $80/hr
Bachelor's degree in Science or Engineering with 4 years of directly related experience . Key ... Provide quality and compliance guidance to senior management regarding quality, compliance, supply ...
QA Specialist- ProQN669
Juncos, PR · On-site
$60 - $80/hr
Bachelor's degree in Science or Engineering with 4 years of directly related experience . Key ... Provide quality and compliance guidance to senior management regarding quality, compliance, supply ...
Senior Csv Engineer information
What is a senior CSV engineer?
Senior CSV Engineers are experienced professionals who specialize in Computer System Validation (CSV) within regulated industries such as pharmaceuticals, biotechnology, and medical devices. Their main responsibility is to ensure that computer systems used in these industries comply with regulatory standards and function as intended. They lead validation projects, develop validation protocols, conduct risk assessments, and work closely with IT and quality assurance teams. Senior CSV Engineers also provide guidance on regulatory requirements, troubleshoot validation issues, and help maintain audit-ready documentation.
What are the key skills and qualifications needed to thrive as a senior CSV engineer?
To excel as a Senior CSV (Computer System Validation) Engineer, you need expertise in validation methodologies, regulatory compliance (such as FDA 21 CFR Part 11, GAMP 5), and a relevant engineering or scientific degree. Proficiency with validation lifecycle documentation, risk management tools, and quality management systems is typically required, as are certifications like PMP or Six Sigma. Strong analytical skills, attention to detail, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring compliance. These skills are essential to maintaining regulatory standards, minimizing risks, and ensuring the integrity and reliability of computerized systems in regulated industries.
What are common challenges faced by senior CSV engineers when ensuring regulatory compliance across multiple projects?
Senior CSV Engineers often encounter the challenge of managing varying compliance standards and documentation requirements across multiple projects, especially when working with global teams. Keeping up-to-date with evolving regulations (such as FDA 21 CFR Part 11 or EU Annex 11) and ensuring that validation activities are harmonized across different systems can be demanding. Strong project management skills, proactive communication with cross-functional stakeholders, and meticulous attention to detail are essential for overcoming these challenges and maintaining audit-ready documentation.
What is the difference between Senior Csv Engineer vs Data Engineer?
| Aspect | Senior Csv Engineer | Data Engineer |
|---|---|---|
| Required Credentials | Bachelor's in Computer Science, Data Science, or related field; experience with CSV processing | Bachelor's or higher in Computer Science, Data Engineering, or related; often includes knowledge of databases and ETL tools |
| Work Environment | Data processing teams, analytics departments, data pipelines involving CSV files | Data infrastructure teams, big data environments, cloud platforms, and data pipelines |
| Employer & Industry Usage | Tech companies, finance, healthcare, any industry handling large CSV datasets | Tech firms, finance, e-commerce, and industries requiring large-scale data integration |
The main difference is that a Senior Csv Engineer specializes in managing and optimizing CSV data workflows, while a Data Engineer has a broader role in designing and maintaining comprehensive data infrastructure, including databases, pipelines, and big data systems. Both roles require similar foundational skills but differ in scope and complexity.
What are popular job titles related to Senior Csv Engineer jobs in Puerto Rico?
For Senior Csv Engineer jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Senior Csv Engineer jobs in Puerto Rico look for?
The top searched job categories for Senior Csv Engineer jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Senior Csv Engineer jobs?
Cities in Puerto Rico with the most Senior Csv Engineer job openings:
Key responsibilities
Review and approve product manufacturing protocols, validation reports, environmental characterization reports, and work orders.
Lead investigations, site audits, and support quality programs, including risk assessments, change controls, and CAPA records.
Provide quality oversight for drug substance manufacturing, testing, storage, and ensure compliance with cGMP, cGLP, and other regulations.
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:
SUMMARY
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
FUNCTIONS
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
EDUCATION
-Doctorate OR
-Masters + 2 years of directly related experience OR
-Bachelors + 4 years of directly related experience OR
Responsibilities
� Execute Quality disposition (approval or rejection) of bulk drug substances.
� Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
� Ensure that deviations from established procedures are identified, reported, and documented per procedures.
� Ensure that changes that could potentially impact drug substance quality are assessed according to procedures.
� Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
� Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations.
� Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress.
� Ensure completion of required training and maintain assigned training adherence to support successful task execution.
� Collaborate and partner cross functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures.
� Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed.
� Alert senior management of quality, compliance, supply, and safety risks.
� Provide support and oversight for New Product Introduction (NPI).
Attributes:
� Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
� Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency.
� Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
� Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
� Validated experience serving as Quality Contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
� Strong organizational skills, with the ability to drive assignments through successful completion.
� Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
� Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.
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.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Specialist QA (5:00 pm - 5:30 am)
SUMMARY
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
FUNCTIONS
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
EDUCATION
-Doctorate OR
-Masters + 2 years of directly related experience OR
-Bachelors + 4 years of directly related experience OR
Responsibilities
� Execute Quality disposition (approval or rejection) of bulk drug substances.
� Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
� Ensure that deviations from established procedures are identified, reported, and documented per procedures.
� Ensure that changes that could potentially impact drug substance quality are assessed according to procedures.
� Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
� Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations.
� Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress.
� Ensure completion of required training and maintain assigned training adherence to support successful task execution.
� Collaborate and partner cross functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures.
� Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed.
� Alert senior management of quality, compliance, supply, and safety risks.
� Provide support and oversight for New Product Introduction (NPI).
Attributes:
� Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
� Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency.
� Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
� Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
� Validated experience serving as Quality Contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
� Strong organizational skills, with the ability to drive assignments through successful completion.
� Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
� Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.
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.
About Pinnaql
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
11 - 50 Employees
Headquarters location
Malvern, PA, US
Year founded
2019