Validation Engineer

CIQA Computer Integration of Quality Assurance - Official; Añasco (PR); In loco; USD 48.000 - 55.000; Tempo pieno

Descrizione del lavoro

CIQA Computer Integration of Quality Assurance - Official in Puerto Rico seeks a hands-on Validation Engineer to support a site readiness project at a regulated manufacturing facility in Añasco. You will execute validation activities, author protocols and maintain QMS documentation.

Ideal candidates have experience in medical device validation, EO/EtO sterilization exposure is a plus, and can work independently while coordinating with suppliers and cross-functional teams.

Competenze

• Bachelors degree in Engineering.
• Experience validating in a regulated industry.
• Hands-on authoring/executing validation protocols.
• Experience with QMS documentation & change controls.
• Minitab or similar statistical software experience.
• Experience with supplier qualification.
• Strong organizational and problem-solving skills.
• Excellent bilingual communication (English/Spanish).
• Ability to work independently with cross-functional teams.

Mansioni

• Develop, author, and execute validation protocols and reports.
• Support site readiness and equipment qualification.
• Ensure validation activities meet regulatory standards.
• Prepare change controls and related technical docs.
• Collaborate with external suppliers to ensure compliance.
• Communicate progress and findings to stakeholders.
• Maintain accurate documentation per procedures.
• Independently perform hands-on validation tasks.

Conoscenze

Validation execution

Documentation writing

Cross-functional collaboration

Communication skills

Bilingual English/Spanish

Formazione

Bachelors degree in Engineering

Strumenti

Minitab

Descrizione del lavoro

We are seeking a hands-on Validation Engineer / Specialist to support a site readiness project at a regulated manufacturing facility in Añasco, Puerto Rico. The ideal candidate will be able to work independently and execute validation activities, develop technical documentation, and collaborate with cross-functional teams and external suppliers to support qualification and implementation activities.

Candidates with medical device industry experience and exposure to EO/EtO (ethylene oxide) sterilization processes are strongly preferred.

Key Responsibilities

• Develop, author, and execute validation protocols, reports, procedures, and related Quality Management System (QMS) documentation.
• Support site readiness, equipment qualification, and implementation activities.
• Execute validation activities in accordance with applicable regulatory requirements, quality standards, and internal procedures.
• Prepare and maintain change controls and other technical documentation as required.
• Use statistical analysis tools, such as Minitab, to support validation activities and data analysis.
• Support supplier qualification activities and collaborate with external suppliers to ensure compliance with applicable quality requirements.
• Work cross-functionally to resolve technical issues, address project needs, and meet project timelines.
• Communicate validation progress, findings, and documentation requirements to relevant stakeholders.
• Independently execute hands-on validation activities while maintaining accurate documentation and adherence to established procedures.

Required Qualifications

• Bachelor's degree in Engineering, preferably in Mechanical, Chemical, Biomedical, Industrial, or a related engineering discipline.
• Experience in validation within a regulated industry; medical device experience is preferred.
• Demonstrated hands-on experience authoring and executing validation protocols and reports.
• Experience preparing procedures, change controls, and other Quality Management System (QMS) documentation.
• Hands-on experience with Minitab or similar statistical analysis software.
• Experience supporting supplier qualification activities and working directly with external suppliers.
• Strong organizational, analytical, and problem-solving skills.
• Excellent written and verbal communication skills.
• Full professional proficiency in both English and Spanish.
• Ability to work independently, execute validation activities, and collaborate effectively with cross-functional teams.

Preferred Qualifications

• Experience with EO/EtO (ethylene oxide) sterilization processes.
• Experience supporting site readiness, qualification, and implementation projects in a regulated manufacturing environment.
• Previous experience in the medical device industry.

Ideal Candidate Profile

The ideal candidate is execution-oriented, technically capable, and comfortable taking ownership of validation activities from documentation development through protocol execution and reporting. This role is best suited for a professional who can independently perform hands-on validation work rather than focus primarily on document review or approval.

Compensation

The hourly rate paid to the candidate will range from $35 to $40 per hour, depending on experience and qualifications.