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.

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The Site Process Engineer (Sterile) 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. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

• 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.

• Bachelor’s degree in Engineering required.
• Minimum 5+ years of experience of technical support and technical transfer in a sterile pharmaceutical manufacturing environment.

• Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
• Working knowledge of EU regulations is preferred.
• 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.
• 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.

• Up to 5% travel required.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places, risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard Additionally, the employee may be required to operate an industrial vehicle.