Site Engineering, Process Engineer II - Belle Oaks Drive Charleston, South Carolina, United States

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 ...

Job description

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.

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.

Qualifications

• Bachelor's degree in Engineering with 3+ years of experience in technical support in a sterile pharmaceutical manufacturing environment.

Knowledge, Skills, and Abilities

• 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.
• 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.

Travel Expectations

• Up to 5% travel expected.

Physical Demands and Work Environment

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 will regularly stand, walk, and use hands, frequently reach, stoop, kneel, crouch or crawl and talk or hear, and occasionally sit and climb or balance. In this role, you will frequently work in an office, lab, or manufacturing areas. You will occasionally be exposed to wet or humid conditions, work near moving mechanical parts, work in high places, near toxic or caustic chemicals, in outdoor weather conditions and exposure to vibration. The noise level that is typical for this position is loud at times when near working equipment.