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Pharmaceutical Validation Remote Jobs in Puerto Rico

... operational interactions with pharmaceutical manufacturers. * Log and track all rebate ... Validate client formularies to ensure compliance with rebate contracts. * Validate that rebate ...

... pharmacist, biotechnology or a related subject. - Fluent in Spanish and English, oral and written ... We recognize the benefits of flexible, remote working arrangements for eligible roles and are ...

Pharmaceutical Validation Remote information

What does a Pharmaceutical Validation Remote professional do?

A Pharmaceutical Validation Remote professional is responsible for ensuring that pharmaceutical processes, equipment, and systems meet regulatory standards and operate as intended, all while working remotely. They review documentation, analyze data, and develop validation protocols to confirm compliance with industry guidelines such as Good Manufacturing Practice (GMP). Their work helps guarantee the safety, quality, and efficacy of pharmaceutical products, even though they complete most tasks off-site using digital collaboration tools. This role often involves coordinating with on-site teams, writing reports, and keeping up-to-date with changing regulations.

What are some typical challenges faced by professionals in remote pharmaceutical validation roles, and how can they be managed?

Remote pharmaceutical validation professionals often encounter challenges such as coordinating with cross-functional teams across different time zones, ensuring secure access to validation documentation, and maintaining clear communication during complex validation processes. To manage these, leveraging robust collaboration tools, establishing regular virtual check-ins, and adhering to strict documentation protocols are crucial. Proactively addressing potential gaps in remote communication and staying updated with regulatory guidelines can also help maintain validation quality and compliance.

What are the key skills and qualifications needed to thrive as a Pharmaceutical Validation Specialist (Remote), and why are they important?

To thrive as a Pharmaceutical Validation Specialist (Remote), you need expertise in validation protocols, regulatory compliance (such as FDA or EMA standards), and a background in pharmaceutical sciences or engineering. Familiarity with validation lifecycle documentation, quality management systems (QMS), and software like TrackWise or Veeva Vault is typically required. Strong analytical thinking, attention to detail, and effective remote communication are crucial soft skills for this role. These competencies ensure that pharmaceutical products and processes meet strict regulatory standards, safeguarding patient safety and product quality.
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Sterilization Program Manager- Ethylene Oxide (EO) (Remote Work)

Sterilization Program Manager- Ethylene Oxide (EO) (Remote Work)

CIS International LLC

Juncos, PR • On-site, Remote

Full-time

Posted 4 days ago


Job description

Summary:
The Sterilization Program Manager is responsible for leading and managing the sterilization project portfolio, including new product launches, validation and revalidation activities, process improvements, and operational support. This role provides technical oversight for Ethylene Oxide (EO) sterilization processes, drives cross-functional collaboration, manages supplier relationships, and ensures compliance with global sterilization regulations and standards.
Key Responsibilities:
Program & Portfolio Management
  • Lead and manage the full sterilization project portfolio, including:
    • New product launches
    • Sterilization validations and revalidations
    • Process improvement initiatives
  • Develop and maintain integrated project plans, timelines, resource allocation plans, and risk registers.
  • Drive alignment across cross-functional teams including R&D, Quality, Regulatory Affairs, Operations, and Supply Chain.
  • Facilitate portfolio prioritization and support trade-off decisions with senior leadership.
  • Establish, monitor, and report key performance indicators (KPIs), project milestones, and program health metrics.
Technical Oversight
  • Serve as Subject Matter Expert (SME) for EO sterilization processes.
  • Provide technical guidance related to microbiological and chemical sterilization methods.
  • Ensure compliance with applicable international regulations, standards, and industry requirements.
  • Support technical problem-solving and troubleshooting efforts across sterilization-related activities.
  • Collaborate with internal SMEs to resolve complex sterilization challenges.
Sterilization & Service Supplier Management
  • Coordinate with internal stakeholders to manage relationships with contract sterilization providers and laboratory service vendors.
  • Support project scheduling and resource planning with external service suppliers.
  • Ensure supplier activities align with project priorities, timelines, and business objectives.
Stakeholder & Change Management
  • Communicate project status, risks, mitigation plans, and key decisions to executive leadership and cross-functional teams.
  • Lead change control activities associated with sterilization process modifications.
  • Promote continuous improvement initiatives and process optimization opportunities.
  • Drive effective stakeholder engagement throughout the project lifecycle.
Requirements
  • Bachelor’s Degree in:
    • Biomedical Engineering
    • Chemical Engineering
    • Microbiology or related scientific/engineering discipline
  • Minimum 3 years of experience in EO sterilization validation and/or sterilization operations.
  • Strong knowledge of sterilization validation lifecycle activities.
  • Experience supporting validation, compliance, and process improvement projects.
Preferred Qualifications
  • PMP Certification or equivalent project management certification.
  • Experience in medical device, pharmaceutical, or regulated manufacturing environments.
  • Knowledge of international sterilization standards and regulatory requirements.
Required Skills
Sterilization & Validation
  • EO Sterilization Processes
  • Sterilization Validation Lifecycle
  • Revalidation Activities
  • Microbiological Methods
  • Chemical Sterilization Methods
  • Regulatory Compliance
Program Management
  • Portfolio Management
  • Resource Planning
  • Project Scheduling
  • Risk Management
  • FMEA
  • Risk Registers
  • KPI Development & Reporting
  • Cross-Functional Leadership
Software & Tools
  • Microsoft Office Suite
  • Microsoft Project
  • Smartsheet
  • Agile Methodologies
Soft Skills
  • Leadership
  • Strategic Planning
  • Stakeholder Management
  • Communication & Presentation Skills
  • Problem Solving
  • Continuous Improvement Mindset
  • Change Management
Work Methodology
  • Remote work reporting to the Juncos, PR site.
  • Full Time Job 
  • Shift: Administrative Shift, but needs to be available for others.
  • Duration: 1 year (with possible extension or conversion depending on project and performance).
  • Professional services Contract
  • Type of industry: Medical devices