Sr. Process Engineer

Responsibilities

• Provides technical assistance for equipment troubleshooting and optimization.
• Owns change controls for new processes and process optimization initiatives.
• Leads cycle and recipe development initiatives for new processes.
• Maintains monitoring of manufacturing processes during production runs to assess technical process issues and provides troubleshooting support as needed.
• Authors manufacturing investigations and completes CAPA assignments.
• Interacts with clients for technical sterile fill finish expertise during routinely scheduled project meetings.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, or Chemistry.
• 5 years of experience of technical support in a sterile pharmaceutical manufacturing environment.
• Previous experience supporting tech transfer of parenteral Drug Products preferred.

Knowledge, Skills, And Abilities

• Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required.
• Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
• Working knowledge of EU regulations preferred.
• Proficiency with Microsoft office (Word, Excel, Outlook) required.
• Ability to interact with internal stakeholders and external customers.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Travel Expectations

• Up to 5% domestic travel.