Validation Engineer II (Temporary)

About the role:

The individual will lead and manage high-level projects that provide Convatec's Haina facility and corporation with significant return on investment or strategic advantage in addition to providing leadership in all process engineering functions.

Key Responsibilities:·

• Apply quality engineering tools and techniques during different phases of product development, product and process transfers, design transfers, process and product changes, and supplier management.
• Responsible for ensuring the compliant implementation of new product and process development, product and process transfers, and product and process changes.
• Responsible for the development, validation, and transfer of test methods for new and existing products and processes.
• Responsible for developing quality plans during the transfer of new products, including raw materials, in-process and final product specifications, process qualification and test method validation, supplier capability assessment, product design validation, and reliability strategies.
• Help develop, suggest and implement modifications, equipment and/or processes that contribute to the improvement of safety, quality and productivity.
• Establishes, develops, and maintains positive relationships with support groups and providers.
• Ask for ideas and opinions to specifically assist in decisions or plans. Actively seeks the opinions and perspectives of individuals of diverse backgrounds and interests.
• Responsible for participating in and supporting all activities related to Global Change Control, CAPA processes, and customer complaints.
• Create and implement changes in validation and Change Control programs to enhance compliance, reduce costs, and improve customer service.
• Lead the periodic review program, ensuring compliance with the timelines established in procedures.

Requirements:

• Bachelor's in science in Science or Engineering.
• Minimum 3 years of experience working in product/process transfer and validations and analytical/statistical techniques such as reliability assessment models, quality function deployment, hypothesis testing, event recurrence, cost analysis, among others.
• Basic understanding and knowledge of regulated quality systems, including FDA/CE/ISO.
• Experience working with Minitab and Microsoft Office.
• Intermediate-Advanced english proficiency is required.

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Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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