Sr. Process Engineer

Alcami Corporation • Morrisville, NC

13d • Onsite

About The Position

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
Are you interested in joining our team?
Job Summary
The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing engineering support for clinical and commercial parenteral Drug Product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: evalutation of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.

Requirements

• Bachelor’s degree in Engineering, Pharmacy, or Chemistry.
• 5 years of experience of technical support in a sterile pharmaceutical manufacturing environment.
• Proficiency with Microsoft office (Word, Excel, Outlook) required.
• Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.

Nice To Haves

• Previous experience supporting tech transfer of parenteral Drug Products preferred.
• Working knowledge of EU regulations preferred.

Responsibilities

• Provides technical assistance for equipment troubleshooting and optimization.
• Own change controls for new processes and process optimization initiatives.
• Lead cycle and recipe development initiatives for new prcoesses.
• Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
• Author manufacturing investigations and complete CAPA assignments.
• Interact 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.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior