Validation Engineer - Plastic Injection

You will be responsible for the development, execution and documentation of validation and revalidation activities for plastic injection molding processes, ensuring compliance with applicable quality and regulatory requirements. This role will work closely with Engineering, Quality and Manufacturing to establish robust and capable molding processes and support continuous improvement initiatives.

Profile:

•Plastics, Mechanical, Industrial Engineer or related field.

•Minimum 3 years of experience in plastic injection molding process validations, preferably within the medical device, pharmaceutical or regulated manufacturing industry.

•Hands-on knowledge and experience with plastic injection molding processes.

•Experience in process validation (IQ/OQ/PQ and PPQ).

•Knowledge of applicable quality and regulatory requirements, including ISO 13485 and ISO 9001

•Experience developing validation plans, protocols and reports.

•Knowledge of Statistical Process Control (SPC) and process capability analysis (Cp, Cpk).

•Knowledge of Design of Experiments (DOE) and statistical analysis.

•Experience with risk analysis and process PFMEA.

•Knowledge of plastic materials and their properties.

•Minitab experience is desirable.

•Intermediate/Advanced English.

Responsibilities:

•Develop and execute validation and revalidation activities for plastic injection molding processes and molds.

•Develop, execute and document IQ, OQ, PQ and PPQ protocols and reports.

•Define and document process parameters and acceptance criteria to ensure robust, repeatable and capable molding processes.

•Perform statistical analysis, SPC and process capability studies to evaluate and demonstrate process performance.

•Apply Design of Experiments (DOE) and statistical tools to establish and optimize process parameters.

•Develop and maintain validation plans, protocols, reports and supporting documentation in compliance with applicable quality and regulatory requirements.

•Perform and support risk assessments and Process FMEAs related to plastic injection molding processes.

•Develop and update Process Sheets and manufacturing process documentation.

•Perform root cause analysis for issues related to molding processes, molds and equipment.

•Partner with Quality to support NCRs, CAPAs, internal/external audits and customer complaints related to manufacturing processes.

•Support qualification of equipment, cleaning processes and associated manufacturing processes.

•Analyze process performance and identify opportunities to improve quality, scrap, efficiency and process robustness.