Sr. Process Engineer

Alcami Corporation • North Charleston, SC

151d • Onsite

About The Position

The Sr. Process Engineer provides technical support for clinical and commercial parenteral Drug Product manufacturing in a fast-paced environment. The role supports technology transfers of new processes and technologies, prepares documentation for process validation and batch manufacturing, troubleshoots manufacturing processes, completes deviations and investigations, and coordinates laboratory studies with the formulation development lab. Work is performed in accordance with standard operating procedures, batch records, FDA and EU requirements, and current Good Manufacturing Practices (cGMP).

This is a 100% on-site, first-shift position, Monday through Friday from 8:00 a.m. to 5:00 p.m. Domestic travel of up to 5% is expected. The role involves frequent standing, walking, sitting, communication, and handling or feeling objects; occasional reaching, climbing or balancing, and tasting or smelling; and frequently lifting or moving up to 25 pounds. The employee may occasionally work near moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals.

Requirements

• Bachelor’s degree in Engineering, Pharmacy, or Chemistry.
• Five years of experience providing technical support in a sterile pharmaceutical manufacturing environment.
• Excellent verbal and written communication, documentation, negotiation, critical thinking, analytical, problem-solving, detail-orientation, organizational, and time-management skills.
• Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
• Proficiency with Microsoft Office, including Word, Excel, and Outlook.
• Ability to interact with internal stakeholders and external customers.

Nice To Haves

• Previous experience supporting technology transfer of parenteral Drug Products.
• Working knowledge of EU regulations.

Responsibilities

• Provide technical assistance for process technology transfer and validation efforts for assigned manufacturing projects.
• Write Master Batch Records with a strong understanding of equipment, critical process parameters, and in-process tests.
• Monitor manufacturing processes during production runs, assess technical process issues, and provide troubleshooting support as needed.
• Author manufacturing investigations and complete CAPA assignments.
• Compose process validation documentation, including CQA assessments, pFMEA risk assessments, and process validation protocols.
• Identify parameters, sampling, and tests for validation protocols for new and existing products.
• Interact with clients during routinely scheduled project meetings.
• Complete company training requirements on time and comply with cGMP and other relevant requirements.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior