Site Engineering, Process Engineer II

Alcami Corporation•North Charleston, SC

8d•Onsite

About The Position

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 (Sterile) II 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. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Requirements

Bachelor's degree in Engineering with 3+ years of experience in technical support in a sterile pharmaceutical manufacturing environment.
Strong analytical and problem-solving skills. Ability to analyze data, identify problems, and develop solutions.
Understanding of manufacturing processes and systems. Knowledge of various manufacturing technologies and equipment.
Effective communication and interpersonal skills. Ability to work effectively with teams, communicate technical information clearly, and collaborate with stakeholders.
Project management skills. Ability to plan, organize, and manage projects effectively.
Familiarity with safety regulations and procedures. Understanding of relevant safety regulations and best practices.
Knowledge of cGMP.
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

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.