Process Engineer - MSAT, GMP, Tech Transfer

Alcami Corporation-posted 4 days ago
Full-time • Mid Level
Onsite • Morrisville, NC
501-1,000 employees
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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 Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers 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 writing reports 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. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm.

  • 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.
  • 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.
  • Working knowledge of EU regulations is preferred.
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