Validation Engineer

**Location**:
Cartago, Costa Rica, CR

**Job Family**: Quality Assurance

**Country/Region**: Costa Rica

Job function summary

The Validation Engineer will be responsible for the execution of process and software validation activities under the organizations as well as maintaining the validation life cycle of the machines, process, and test method, ensure compliance within external and internal requirements and ensure compliance to the quality management system.

Major areas of accountability
- Issuing, completing, or approving validation documentation (protocols, deviations, reports, etc.)
- Performing Installation, Operational, and Performance Qualification of equipment, instruments, and machines.
- Performing validation of test methods for continues data and attributes.
- Performing assessment about software changes and perform validation of software as appropriate
- Creation of software validation plans and validation strategic plans as required
- Issuing, updating, and approving Process Risk assessments
- Investigating abnormal test results (close collaboration with Quality Engineer and Production Support Engineers and stakeholders).
- Troubleshooting validation issues (close collaboration with Quality Engineer and Production Support Engineers and stakeholders).
- Handling of Process validation, Software validation and Risk assessments related Change Request tasks.
- Collecting, organizing, and documenting test data.
- Statistical analysis of data for process and test methods validation.
- Ensuring accurate records of all validation activities.
- Performing activities in a timely manner.
- Performing with focus in the Corporate and department KPIs
- Participation in internal and external audits as required.
- Maintaining validation documentation throughout the validation life cycle.
- Comply with internal and external instructions and work discipline in connection with work.
- Participation on cross-functional teams related to projects for new machines, transfer machines, item extensions or any other project where validation assessment or validation activity is needed.
- Executes tasks to the ordinance of the superior or upon his initiative, which are not listed in the job description, but based on the job it is part of his job, or in case of emergency or if it is additional part of his job
- Performing their job in compliance with the guidelines given
- Drawing attention to the manager to any difficulties in understanding or following the guidelines
- Drawing attention to inefficiency of the system
- Take responsibility for those safety aspects identified for the given position

Additional Areas of Accountability
- Performing their job in compliance with the guidelines given
- Drawing attention to the manager to any difficulties in understanding or following the guidelines
- Drawing attention to inefficiency of the system

Essential qualifications
- Bach. degree in an Engineering field, such industrial, electrical, mechanical, etc.
- Understanding and Knowledge of the quality system standards ISO 13485 and ISO 9001.
- Experience in regulated industries (e.g., medical device industry).
- Experience with Microsoft Office package (Word, Excel, PowerPoint, Outlook).
- Experience with statistical software such as JMP, Minitab, etc.
- Min. 3 years of experience in quality or production roles.
- Fluent in both spoken and written English

Preferred qualifications
- Numerical skills and understanding of data analysis/statistical methods.
- Experience performing in validation roles
- Mobile; capacity to travel abroad to received training and support transfer activities

Required knowledge, skills & abilities

Functional competencies*
- Quality Systems & Processes
- Statistical Analysis & Tools
- Technical Writing & Documentation
- Regulatory Landscape
- Standards & Regulations
- System & Data Management
- Validation
- Design Control

Cross-functional competencies
- Project Management
- Self-Management
- Decision-making
- Collaboration
- Communication

Why Coloplast?

Coloplast develops products and services that make life easier for people with personal and private medical conditions. Working closely with the people who use our products, we create solutions that are sensitive to their special needs. We call this Intimate healthcare.

We are guided by three values

Closeness we work closely with our customers to find solutions that meet their specific needs
Passion we work passionately to create new and innovative products that improve the quality of life for our customers
Respect and responsibility we have deep respect for the private nature of the condition our customers face. Therefore, it’s our responsibility to find not only medical solutions, but also ways to minimize the trauma and taboo associated with these conditions

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14.000 people