Associate Validation Engineer

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Position Overview: Position Overview:

• The Associate Engineer supports validation teams in ensuring new products, systems, or processes meet specified standards through documentation, testing, and data analysis under the guidance of senior staff. Key duties include preparing validation plans, documenting processes, performing tests, analyzing data, identifying issues, and maintaining compliance with regulatory standards. The (AE) must be proficient in strong analytical, communication, and technical writing skills, as well as attention to detail and the ability to work with cross-functional teams.

Responsibilities:

• Develop and execute protocols to validate new and existing systems, processes, equipment, and software to ensure they consistently produce expected results.

• Support Insulet Global and Malaysia Plant Engineering in all equipment and process validation activities includes but not limited to: FAT, SAT, IQ, TMV, OQ and PQ.

• Perform tests, evaluations, and calibrations on equipment and instruments to ensure they are functioning correctly and meet specifications.

• Prepare and review detailed validation reports, deviations, and other critical documents to ensure compliance with internal procedures and regulatory standards.

• Autonomously interpret data to drive cost savings projects.

• Ensure that all validation activities adhere to relevant regulatory guidelines, such as Good Manufacturing Practices (GMP), FDA, ISO standards and Insulet procedure.

• Ensure compliance with safety rules, quality policies, and employee guidelines.

• Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance to ISO 13485.

• Perform other duties as required.

Minimum Requirements: Preferred Skills and Competencies:

• Analyse data, identify issues or non-conformances, and recommend or implement corrective actions to improve process efficiency and product quality.

• The ability to analyse data using various operating systems and programs and to develop intra-department teams to establish goals and take corrective actions to improve performance.

• Collaboration with QA, manufacturing, research, and other engineering teams to integrate validation activities into product development and manufacturing lifecycles.

• A combination of education, training, and experience that results in demonstrated competency to perform the work may be substituted.

• Have strong interpersonal and communication skills.

• Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively.

• Planning Skills – Sets goals and priorities, thinks ahead, and identifies activities and resources needed to achieve goals.