Sr. Process Engineer

Alcami Corporation; Morrisville (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

Alcami Corporation is looking for a Sr. Process Engineer to provide engineering support for parenteral Drug Product manufacturing. This role involves evaluating new processes, troubleshooting issues, and ensuring compliance with regulatory standards.

The ideal candidate will have a Bachelor's degree in Engineering, Pharmacy, or Chemistry and at least 5 years of experience in a sterile pharmaceutical environment. The position is 100% on-site in Morrisville, NC.

Qualifications

• 5 years of experience providing technical support in a sterile pharmaceutical manufacturing environment.
• Previous experience supporting tech transfer of parenteral Drug Products preferred.

Responsibilities

• Provides technical assistance for equipment troubleshooting and optimization.
• Owns change controls for new processes and process optimization initiatives.
• Leads cycle development initiatives for new processes.
• Monitors manufacturing processes during production runs.
• Author manufacturing investigations.
• Interacts with clients for technical expertise.
• Ensures compliance with cGMP and training requirements.

Skills

Excellent verbal communication

Written communication

Critical thinking

Analytical skills

Problem-solving

Detail orientation

Time management

Education

Bachelor's degree in Engineering, Pharmacy, or Chemistry

Tools

Microsoft Office (Word, Excel, Outlook)

Job description

Sr. Process Engineer

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 Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing engineering support for clinical and commercial parenteral Drug Product manufacturing. Responsibilities include evaluating new processes and technologies, preparing 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 are 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.

Responsibilities

• Provides technical assistance for equipment troubleshooting and optimization.
• Owns change controls for new processes and process optimization initiatives.
• Leads cycle and recipe development initiatives for new processes.
• 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.
• Interacts with clients for technical sterile fill finish expertise during routinely scheduled project meetings.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• Bachelor's degree in Engineering, Pharmacy, or Chemistry.
• 5 years of experience providing technical support in a sterile pharmaceutical manufacturing environment.
• Previous experience supporting tech transfer of parenteral Drug Products preferred.

Knowledge, Skills, and Abilities

• Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization, and time management skills required.
• Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
• Working knowledge of EU regulations preferred.
• Proficiency with Microsoft Office (Word, Excel, Outlook) required.
• Ability to interact with internal stakeholders and external customers.

Travel Expectations

• Up to 5% domestic travel.

Physical Demands and Work Environment

The physical demands 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 required to frequently stand, walk, sit; talk or hear; use hands to finger, handle or feel. The employee is required some of the time to reach with hands and arms. The employee is required occasionally to climb or balance; and taste or smell. The employee must frequently lift and/or move up to 25 pounds. There is no special vision requirement for this job. The employee may occasionally work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals.