Process Engineering Senior

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.

Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. 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 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.

Interact with clients during routinely scheduled project meetings.

Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Bachelor’s degree in Engineering, Pharmacy, or Chemistry.

5 years of experience of technical support in a sterile pharmaceutical manufacturing environment.

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.

Travel Expectations

Up to 5% domestic travel.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee may occasionally work near moving mechanical parts; toxic or caustic chemicals.

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