Validation Specialist

INNOBAL CORP.; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

INNOBAL CORP. in Guaynabo, Puerto Rico, seeks a Validation Specialist for an on-site role in Juncos to plan, execute, and document validation activities for equipment, systems, and processes in pharmaceutical manufacturing.

You will prepare validation protocols and reports, perform testing and data collection, review results against acceptance criteria, and ensure compliance with cGMP, FDA/EMA expectations.

Qualifications

• Proficient in Computer System Validation including protocol development, execution, and documentation in regulated environments.
• Strong experience with Process Validation, including equipment qualification, process performance qualification, and ongoing verification.
• Knowledge of validation methodology, risk assessment, and maintaining validated status for systems and processes.

Responsibilities

• Plan, execute, and document validation activities for equipment, systems, and processes in pharmaceutical manufacturing facilities.
• Prepare validation protocols and reports; perform testing and data collection; review results against acceptance criteria.
• Ensure compliance with cGMP, FDA, EMA, and other regulatory expectations; support audits and change control.

Skills

Computer System Validation

Process Validation

Validation methodology

Quality Assurance

Regulatory compliance in pharma

English language proficiency

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Validation software tools

Job description

Company Description INNOBAL CORP. is an engineering services company based in Guaynabo, Puerto Rico, specializing in support for the pharmaceutical industry. The organization provides expertise in project management, validation, automation, project engineering, and manufacturing processes. INNOBAL CORP. partners with pharmaceutical clients to improve operational reliability, regulatory compliance, and efficiency across facilities and systems. Team members collaborate on complex technical projects and contribute to solutions that sustain high-quality pharmaceutical manufacturing environments.
Role Description The Validation Specialist is a full-time, on-site role located in Juncos, Puerto Rico. This role is responsible for planning, executing, and documenting validation activities for equipment, systems, and processes in pharmaceutical manufacturing facilities. Daily tasks include preparing validation protocols and reports, performing testing and data collection, reviewing results against acceptance criteria, and ensuring compliance with relevant regulatory and industry standards. The Validation Specialist will collaborate with engineering, manufacturing, quality assurance, and automation teams to troubleshoot issues, implement corrective actions, and maintain validated states. The role also involves participating in audits, supporting change control activities, and contributing to continuous improvement initiatives related to validation and quality.
Qualifications

• Candidates should possess strong skills in Computer System Validation, including protocol development, execution, and documentation in regulated environments.
• Candidates should possess solid Process Validation experience, covering equipment qualification, process performance qualification, and ongoing process verification.
• Candidates should possess skills in Validation methodology, risk assessment, and maintaining validated status for systems and processes.
• Candidates should possess competencies in Quality Control and Quality Assurance, with an understanding of cGMP, FDA, EMA, and other relevant regulatory expectations.
• Relevant qualifications include a bachelor's degree in Engineering, Life Sciences, or a related technical field, or equivalent practical experience in pharmaceutical or biotech industries.
• Additional beneficial skills include strong analytical and problem-solving abilities, proficiency with technical documentation, and familiarity with validation software tools and data integrity principles.
• Effective communication, teamwork, and organizational skills, including the ability to manage multiple validation projects and meet deadlines, are expected.
• Experience working in pharmaceutical manufacturing environments and fluency in English (Spanish proficiency is a plus) are advantageous.