Senior Production specialist (Closed)

Tensive; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A biomedical startup is seeking a Senior Production Specialist to enhance production and quality control processes. The ideal candidate will have experience with Class III medical devices, strong skills in organic chemistry, and be able to work in a cleanroom environment. Responsibilities include implementing production improvements, conducting quality control tests, and maintaining production equipment. Join a team dedicated to innovative prosthetic development and patient quality of life.

Competenze

• Experience in producing Class III medical devices or in the pharmaceutical field.
• At least 3 years of experience in process upscaling and manufacturing.
• Proficiency in English, both spoken and written.

Mansioni

• Evaluate and implement improvements to production methods.
• Collaborate to draft periodic analysis reports.
• Conduct quality control tests according to standards.
• Perform maintenance and cleaning of equipment.

Conoscenze

Organic Chemistry Synthesis

Quality Management Systems

Problem-solving

Technical Communication

Formazione

Bachelor's degree in Chemistry or Pharmaceutical Sciences

Strumenti

Microsoft Office

Descrizione del lavoro

Tensive is a biomedical startup developing innovative prostheses aimed at offering natural breast reconstruction or augmentation to improve patients’ quality of life. The production team is seeking a Senior Production Specialist (SPS) to support production and quality control activities.

We value collaborative individuals with a passion for learning and a team spirit. Our team invests heavily in coaching new hires.

Responsibilities

• Evaluate, recommend, and implement lean and root-cause-analysis-based measures to continuously improve production methods, equipment performance, product quality, integrity, and efficiency.
• Collaborate with the Production Manager to draft periodic analysis reports, showing production outputs and statistics.
• Share knowledge and experience with the production team, contributing to raising the technical training level, especially related to production steps including synthesis of polymeric precursors and processing.
• Perform manufacturing activities in an ISO 7 cleanroom for Class III medical devices.
• Conduct quality control tests on production intermediates and final products according to internal procedures and standards.
• Participate in managing non-conformities, including drafting reports, investigating root causes, implementing preventive and corrective actions, and documenting these processes.
• Design, execute, and report on tests for manufacturing process validation.
• Perform installation, operation, and performance qualification of production equipment.
• Monitor environmental conditions and parameters of the cleanroom.
• Perform maintenance and cleaning of equipment and the cleanroom.
• Maintain and update production records, templates, and documentation.
• Draft and revise Standard Operating Procedures (SOPs) and work instructions (WIs).
• Verify maintenance and calibration status of production equipment and instruments.

Requirements

• Previous experience in producing Class III medical devices or in the pharmaceutical field, with knowledge of quality management systems.
• Bachelor’s degree in chemistry, pharmaceutical sciences, or related technical disciplines.
• Experience and skills in organic chemistry synthesis, scaling from 5-10kg per synthesis.
• At least 3 years of experience in process upscaling and manufacturing system design.
• Willingness to work in a controlled cleanroom environment, wearing appropriate clothing and PPE.
• Availability to work on a 2-shift basis.
• Knowledge of organizational, operational, and technical aspects of medical device or pharmaceutical production.
• Proficiency in English, both spoken and written.
• Good knowledge of Microsoft Office.

We also seek individuals with strong skills in chemistry, biology, and biomaterials for future openings. If interested, please email your resume and areas of interest.

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