Manufacturing Specialist III supports the manufacturing team with technical expertise on complex pharmaceutical production tasks while ensuring FDA and regulatory compliance. The role involves developing manufacturing documentation, leading quality management activities, and serving as a subject matter expert for continuous process improvement in a sterile/aseptic manufacturing environment.

Responsibilities

- Develop, define, and review complex manufacturing documentation including procedures and work instructions
- Lead quality event management including change controls, deviations, and corrective/preventive actions
- Identify, promote, and execute continuous improvement initiatives to optimize processes and reduce costs




- Provide technical expertise on manufacturing equipment and lead validation and qualification activities
- Train plant personnel on developed procedures and provide on-site technical support as subject matter expert

Requirements

- Minimum 4 years professional experience, preferably in sterile pharmaceutical products or aseptic processes
- University degree in Engineering, Pharmacy, Biology, Biotechnology, or related biosciences
- High proficiency in oral and written Spanish and English
- Solid knowledge of pharmaceutical manufacturing processes
- Ability to adapt, work cross-functionally, and manage multiple priorities

📌 Manufacturing Specialist III (España)
🏢 PCI Pharma Services
📍 España