Alcami Corporation · 3 weeks ago
Process Engineer - MSAT, GMP, Tech Transfer
US-NC-Morrisville
Full-time
Onsite
Entry, Mid Level
2+ years expAlcami Corporation is dedicated to delivering reliable solutions for transformative medicines. The Process Engineer will provide technical support for clinical and commercial parenteral Drug Product manufacturing, focusing on tech transfers, process validation, and troubleshooting manufacturing processes.
Pharmaceuticals
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, in-process tests, etc
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
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
Interact with clients during routinely scheduled project meetings
Ensures timely completion and compliance with cGMP and all other relevant company training requirements
Other duties as assigned
Qualification
Required
Bachelor's degree in Engineering, Pharmacy, Chemistry, or related field required
Minimum 2 years of experience of technical support and technical transfer in a sterile pharmaceutical manufacturing environment
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
Proficiency with Microsoft office (Word, Excel, Outlook) required
Ability to interact with internal stakeholders and external customers
Preferred
Working knowledge of EU regulations
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase