R&D Sterile Manufacturing Process Engineer
4 settimane fa
About the Role
We are seeking a highly skilled Process Engineer to join our R&D team in Sterile Manufacturing. As a Process Engineer, you will play a key role in supporting the development and implementation of new manufacturing processes for sterile products.
Key Responsibilities
Implement technical solutions at Pilot Plant to enable manufacturing of new drug products, with specific focus to new equipment and single-use system (SUS) qualification.
Define in conjunction with R&D project teams of the user requirements of the equipment/SUS
Define equipment design and technical specifications.
Addend, with Parma Procurement, to commercial tender with suppliers and cooperate with suppliers to elaborate technical solution and design of the equipment.
Be responsible of FAT/SAT of the equipment and execute documentation and on field activities to qualify the equipment/SUS
Elaborate plans and keep on track activities to deliver the equipment/SUS according to R&D project timelines.
Support Manufacturing Operation with training on equipment/SUS and SOPs.
Requirements
Master's degree in Chemical or Mechanical Engineering.
Good written and spoken knowledge of Italian and English.
Good attitudes to team working and interactions with vendors / international stakeholders.
Experience in validation of pharmaceutical manufacturing process equipment
Experience in change control management process
Basic knowledge of aseptically filled drug products manufacturing process and related GMPs.
What We Offer
Permanent contract in a very Inclusive environment
Smart Working
Flexible Benefits
Company Healthcare Plan
Integrative pension fund
Employee Assistance Programme
Sustainable mobility programme
Company canteen
Performance Reward
If you are a motivated and experienced Process Engineer looking for a new challenge, please submit your application. We look forward to hearing from you.
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