Senior Process Engineer

1d1 day ago

Alcami Corporation

Charleston, US · Full-time · $95,000 – $125,000

About this role

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization. The Senior Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing.

Day-to-day responsibilities include performing tech transfers of new processes and technologies into the site, preparing documentation to support process validation and batch manufacturing, and troubleshooting manufacturing processes. The role also involves completing process deviations and investigations, and coordinating lab studies with the formulation development lab.

This position operates within a sterile pharmaceutical manufacturing environment following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices. The engineer will interact with clients during routinely scheduled project meetings and ensure timely completion of cGMP training.

This is a 100% on-site, first shift role offering the opportunity to work on transformative medicines from early-stage clinical through commercial production. The position provides exposure to tech transfer, validation, and continuous improvement in a regulated, high-quality environment.

Requirements

Bachelor’s degree in Engineering, Pharmacy, or Chemistry.
5 years of experience providing technical support in a sterile pharmaceutical manufacturing environment.
Previous experience supporting tech transfer of parenteral Drug Products preferred.
Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills.
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).
Ability to interact with internal stakeholders and external customers.

Responsibilities

Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
Writes Master Batch Records with a strong understanding of equipment, critical process parameters, and in-process tests.
Monitors manufacturing processes during production runs to assess technical issues and provides troubleshooting support as needed.
Authors manufacturing investigations and completes CAPA assignments.
Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.
Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.
Interacts with clients during routinely scheduled project meetings.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Benefits

100% on-site position with a consistent first shift schedule (Monday - Friday, 8:00am - 5:00pm).
Opportunity to work on transformative medicines from discovery to commercialization.
Exposure to both clinical and commercial parenteral Drug Product manufacturing.
Up to 5% domestic travel for project-related activities.