Packaging/Process Engineer

Sunrise System Inc. is currently looking for

• Support investigations and tracks product complaint trends related to primary components. This includes
• Forensic analysis of complaints, understanding usage, conducting Design of Experiments, and application of other
• Engineering tools to determine root cause and ensure components and materials meet Client performance and quality standards
• Develop primary container specifications, incoming test methods for commercial parenteral products, and supports primary packaging related regulatory filings.
• Employ project management practices for developing project timelines, resources, monitoring progress and project status communication.
• Support Manufacturing sites, Procurement, Global Quality and Compliance in supplier, customer, internal, and/or regulatory agency audits and provide technical leadership of supplier robustness, which includes assessments of
• component manufacturers' supply capability.
• Collaborate cross-functionally to promote awareness and ensure compliance to new regulatory policies, regulations, directives, and other issues related to primary packaging systems.
• Collaborate with primary container development, secondary packaging, marketing, supply chain, global
• Procurement, logistics, internal and external manufacturing sites, to successfully develop, tech transfer and launch packaged products

• Bachelor's degree with 1-3 years of professional experience in pharmaceutical (sterile product manufacturing is preferred), healthcare, food, or cosmetic industries.
• Solid background in primary packaging components, such as glass and plastic containers, rubber closures, seals, syringes.
• Experience in writing, executing, reporting, and presenting packaging system evaluations.
• Strong understanding of global regulations regarding packaging is preferred
• Excellent interpersonal, oral, and written communication skills
• Able to manage multiple tasks with minimal supervision and independently prioritize activities based on timelines