Site Engineering, Sr. Process Engineer

Alcami Corporation•North Charleston, SC

8d•Onsite

About The Position

The Site Process Engineer (Sterile) for our parenteral site in Charleston, SC is accountable for driving results in a fast-paced environment by providing technical support for the manufacturing facility, including, troubleshooting equipment, validated processes, process deviations and investigations, transfers of new processes and technologies into the site and preparation of documentation to support validation and process transfer activities. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Requirements

Bachelor’s degree in Engineering required.
Minimum 5+ years of experience of technical support and technical transfer in a sterile pharmaceutical manufacturing environment.
Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
Good verbal and written communication skills.
Ability to successfully multitask and prioritize assignments.
Good computer skills including Microsoft Office products.
Ability to work independently as well as on a team.

Nice To Haves

Working knowledge of EU regulations is preferred.
Some understanding of pharmaceutical manufacturing and packaging of parenterals principles of technology transfer, process investigations, scale-up, process validation and optimization of liquid fill dosage forms; and lyophilization and sterilization would be helpful.

Responsibilities

Provides technical assistance for process transfer and validation efforts for assigned manufacturing areas.
Analyze existing processes, identify areas for improvement, and implement changes to enhance efficiency, reduce costs, and improve product quality.
Develop new or modified processes, equipment, and layouts to meet specific production goals.
Composes process validation, cleaning validation, or process optimization protocols
Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.
Writes validation and technical improvement reports.
Monitors manufacturing processes during production runs to assess any technical process issues.
Assists technicians in performing physical testing during the aseptic manufacturing operation (e.g. sterilization, depyrogenation, lyophilization, and sanitization).
Participate in investigations and complete CAPA assignments.
Utilizes FMEA to trouble shoot processing issues.
Participates in Capital Project planning process including identifying requirements, project scope documentation, and review of other engineering design documentation.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.