R&D Sterile Manufacturing Process Engineer
5 giorni fa
Job Summary
Glaxosmithkline is seeking a Process Engineer to support clinical manufacturing business growth at Global Supply Chain Parma. The successful candidate will work on projects in cooperation with GSC Parma and the R&D Project teams.
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 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 for 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.
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