Sr Engineer-OSD MSAT

Alkermes • Wilmington, OH

55d

About The Position

The Manufacturing Science and Technology Engineer will be critical in supporting the manufacturing processes of oral solid dosage forms. This position involves ensuring efficient and compliant production, troubleshooting technical issues, and driving continuous improvement initiatives.

Requirements

• Education: Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field.
• Experience: Minimum of 5-10 years of experience in pharmaceutical manufacturing, with a technical focus on oral solid dosage forms.
• Technical Skills: Strong understanding of OSD manufacturing processes, equipment, and technologies. Proficiency in data analysis and process optimization.
• Problem-Solving: Excellent troubleshooting and problem-solving skills.
• Communication: Strong written and verbal communication skills. Ability to work effectively with both technical and non-technical teammates.
• Regulatory Knowledge: Familiarity with GMP, FDA regulations, and other relevant industry standards.

Nice To Haves

• Familiarity with JMP stats software and coding in JSL, SQL, JAVA, HTML, and/or Python is desired.

Responsibilities

• Process Support: Provide technical support for the manufacturing of oral solid dosage forms, ensuring processes are efficient, compliant, and meet quality standards.
• Technology Transfer: Collaborate with cross-functional teams to facilitate the transfer of new processes and products into commercial manufacturing.
• Troubleshooting: Identify and resolve technical issues related to equipment, processes, and materials to minimize production downtime.
• Continuous Improvement: Lead and participate in continuous improvement projects to enhance process efficiency, product quality, and cost-effectiveness.
• Documentation: Author and review technical documents, including batch records, standard operating procedures (SOPs), and technical reports.
• Compliance: Ensure all manufacturing activities comply with regulatory requirements, Good Manufacturing Practices (GMP), and company policies.
• Data Analytics: Analyze process data to identify trends, optimize processes, and support decision-making.
• Collaboration: Work closely with Manufacturing, Quality Assurance, Quality Control, Supply Chain, Process Development and other departments to ensure seamless operations and new improvement/technology installation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 1,001-5,000 employees