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Computer System Validation Csv Pharmaceutical Jobs in Bayamon, PR

Veg Group

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

Juncos, PR · On-site

$80 - $100/hr

Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug ... Experience in computer systems validation (CSV) or computer systems quality assurance, including ...

PACIV

IT / CSV Specialist

San Juan, PR · On-site

... systems, infrastructure, and validation activities within a pharmaceutical manufacturing ... Bachelor's degree in IT, Computer Science, Engineering, or a related field preferred.

Pinnaql

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

Juncos, PR · On-site

Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug ... Experience in computer systems validation (CSV) or computer systems quality assurance, including ...

Pinnaql

C&Q Specialist

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.

Pinnaql

C&Q Specialist

Gurabo, PR · On-site

... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Cencora

Sr. Automation Engineer

Juncos, PR · On-site

$101K - $132K/yr

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Serve as a recognized Engineering Subject Matter Expert (SME ...

Mentor Technical Group

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)

Frey Consulting Group

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 ...

Veg Group

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.

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Computer System Validation Csv Pharmaceutical information

See Bayamon, PR salary details

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How much do computer system validation csv pharmaceutical jobs pay per hour?

As of Sep 8, 2026, the average hourly pay for computer system validation csv pharmaceutical in Bayamon, PR is $48.93, according to ZipRecruiter salary data. Most workers in this role earn between $37.69 and $58.03 per hour, depending on experience, location, and employer.

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?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining 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 job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Bayamon, PR look for?

The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Bayamon, PR are:

What cities near Bayamon, PR are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities near Bayamon, PR with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you

Automation SME - Project Engineer

JC Automation

Manati, PR • On-site

$100 - $125/hr

Other

Posted 18 days ago

Key responsibilities

  • Lead the development, planning, and execution of Automation/IT/Network Capital Projects.

  • Coordinate engineering, quality, validation, IT, and vendors through all project phases to ensure project scope, schedules, costs, and risks are managed.

  • Support the design, specification, procurement, installation, commissioning, and start-up of automation and computerized systems.

Job description

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

The Automation SME – Project Engineer is accountable for technical leadership and project coordination of assigned Automation/IT capital projects. Execution activities may be performed directly by the resource or through oversight and coordination of contractors and system integrators. As a candidate, your company must meet BMS policies, guidelines, and other requirements.

2.1. Capital Project Execution
  • Lead the development, planning, and execution of Automation/IT/Network Capital Projects.
  • Act as the technical project lead for Automation/IT scope, coordinating engineering, quality, validation, IT, and vendors through all project phases.
  • Define project scope, schedules, cost estimates, risks, and deliverables.
  • Provide routine project status reporting, milestone tracking, and risk mitigation plans.
  • Resolve complex technical and design issues arising during project execution, construction, and start‑up, ensuring decisions support regulatory compliance, safety, product quality, cost, and schedule objectives.
  • Provide clear and timely communication on Project Engineering activities, risks, and milestones to internal stakeholders and management. Support Capital Appropriation Requests (CARs), budgeting, and financial tracking.
  • Coordinate project execution activities with EHS to ensure compliance with safety, environmental, and waste‑handling requirements throughout all project phases.
  • Review vendor quotations, develop technical specifications, and support procurement activities, including purchase requisitions and technical evaluation of equipment and services for Automation/IT capital projects.
2.2. Automation and Systems Engineering
  • Lead and/or support the design, specification, procurement, installation, commissioning, and start-up of automation and computerized systems.
  • Provide SME support for systems including, but not limited to:
  • PLCs, HMI, SCADA, DCS/BAS o DeltaV, Rockwell Automation, FactoryTalk, Siemens, Wonderware o MES systems (e.g., Syncade), data historians (OSI PI), databases (MS SQL), and virtualization platforms
  • Review and approve automation architectures, network designs, and system configurations.
  • Identify and promote best available automation technologies to meet site and corporate needs. 2.3. Compliance, Quality, and Validation
  • Ensure all project activities comply with: o cGMP, FDA, EMA, OSHA, EPA/EQB o 21 CFR Part 11, Engineering, IT, and Security standards
  • Support execution of the Computer System Validation (CSV) lifecycle, including requirements, specifications, testing, and qualification.
  • Support Performance Qualification (PQ) of equipment and systems installed under capital projects.
  • Participate in quality events, including deviations, investigations, CAPAs, internal audits, and regulatory inspections related to automation systems.
  • Ensure Automation and computerized systems are delivered in a validated state, in compliance with CSV requirements.
  • Support preparation, review, and execution of validation documentation.
2.4. Contractor and Vendor Management
  • Manage and coordinate external contractors, system integrators, and vendors.
  • Ensure contractor compliance with safety, environmental, security, and quality requirements.
  • Review technical proposals, quotations, and specifications.
  • Coordinate FAT, SAT, commissioning, and start‑up activities with vendors and internal stakeholders.
  • Ensure quality of construction, installation, and system implementation activities for Automation and related infrastructure in accordance with approved designs, specifications, and GMP requirements.
2.5. Documentation and Change Control
  • Develop, review, and maintain technical and project documentation, including:
  • URS, FRS, DS, and configuration documents.
  • SOPs (Operations, Maintenance, Security, Backup/Restore, Disaster Recovery).
  • Execute and support change control activities related to automation and computerized systems.
  • Ensure proper documentation control, traceability, and data integrity.
2.6. Cross‑Functional Collaboration
  • Serve as the Automation Project SME for Manufacturing Business Units.
  • Collaborate with Manufacturing, Quality, Engineering, Maintenance, IT, EHS, Purchasing, and Corporate teams.
  • Provide technical guidance to resolve complex operational and project-related issues.
  • Support client initiatives by ensuring adherence to Project Management processes and governance.
REQUIREMENTS & QUALIFICATIONS Required

The assigned resource must meet the following minimum qualifications:

  • Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field.
  • Minimum five (5) years of experience in pharmaceutical operations or manufacturing environments with proven project management experience, of which: o At least four (4) years must be in process automation within a pharmaceutical environment o At least two (2) years must be in computerized systems validation (CSV).
  • Demonstrated proficiency in computer system lifecycle concepts, change control processes, and FDA regulatory requirements, including 21 CFR Part 11.
  • Proven experience developing and reviewing Computerized Functional Requirements (CFR/URS) and Design Specifications (DS/FRS).
  • In-depth knowledge of the design, installation, commissioning, and qualification of computerized systems, PLCs, and automation platforms in pharmaceutical manufacturing.
  • Broad knowledge of cGMPs, FDA, EMA, and applicable regulatory guidelines for biopharmaceutical manufacturing facilities.
  • Experience supporting internal and external regulatory audits (e.g., FDA, EMA). Strong understanding of pharmaceutical manufacturing processes, equipment, and automation systems.
  • Knowledge of electrical controls theory, mechanical concepts, and electronic circuitry, with ability to read and interpret electrical and mechanical drawings.
  • Proven skills in project management, systems development, and implementation of manufacturing automation, MES, and quality-related systems.
  • Experience with PLC programming platforms, data acquisition systems, historians (e.g., OSI PI), databases (e.g., MS SQL), and industrial networking infrastructures.
  • Ability to review and support development of SOPs and work instructions.
  • Strong analytical and problem-solving skills, with ability to resolve complex technical issues based on data.
  • Fully bilingual English/Spanish, written and verbal.
  • Strong interpersonal skills with ability to work effectively across all organizational levels and disciplines.
  • Ability to manage and prioritize multiple complex activities simultaneously.
  • Self‑starter, well organized, flexible, and able to meet deadlines.
  • Willingness to work irregular hours, weekends, and holidays as required.
  • Ability to exercise good judgment.
Preferred
  • Experience with CMMS systems (e.g., Maximo).
  • High level of expertise in Rockwell Automation platforms.
  • Experience with Siemens, Wonderware, and FactoryTalk Batch.
  • Experience with virtualization platforms (VMware vSphere).
  • Experience with MES systems (e.g., Syncade).
  • Experience with OSIsoft / AVEVA PI systems and Microsoft SQL databases.
SKILLS Technical Skills
  • PLCs, HMI, SCADA, DeltaV, FactoryTalk — advanced configuration and troubleshooting
  • MES systems — support and integration
  • Change control execution and CAPA support in regulated environments
  • Automation procedure development — SOPs, security plans, backup/restore, disaster recovery
  • cGMP, 21 CFR Part 11, and Data Integrity compliance
  • Quality event investigation and internal audit support
  • Network configuration and industrial communication protocols
  • Microsoft Office 365
Soft Skills
  • Deep technical ownership of automation systems
  • Clear communication with Manufacturing, Quality, IT, and Engineering teams
  • Proactive risk identification and escalation
  • Disciplined in regulatory documentation and change management
  • Project milestone accountability
  • Consulting mindset — advising on technology use and process improvement
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