Senior Aseptic Process Engineer Contract Baltimore

Actalent; Baltimore (MD); On-site; USD 138,000 - 172,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Spending Account

Transportation benefits

Employee Assistance Program

Paid Time Off

Job summary

Actalent in Baltimore, MD is seeking a Senior Aseptic Process Engineer to lead evaluation, vendor collaboration, and implementation planning for aseptic process improvements in a regulated manufacturing setting. The role requires deep experience with legacy aseptic filling operations, single-use systems, and GMP engineering to reduce open exposure and improve process robustness.

You will translate contamination risks into technical requirements, develop URS and process diagrams, and guide

Qualifications

• Bachelor's degree in engineering or related discipline; advanced degree a plus.
• Approximately 10+ years of experience in process engineering within sterile pharmaceutical or biologic manufacturing.
• Experience in improving or modernizing legacy aseptic filling operations.
• Direct experience with vial and/or syringe filling and sterile filtration.
• Understanding of first-air protection and contamination mechanisms.
• Experience with single-use systems and aseptic connectors.
• Working knowledge of GMP engineering and design expectations.
• Ability to develop detailed engineering documentation.

Responsibilities

• Assess legacy aseptic filling and setup practices, including equipment and component reviews.
• Translate contamination mechanisms and intervention-risk findings into engineering requirements and design concepts.
• Lead technical evaluations of single-use bags, tubing assemblies, and closed-product-pathway options.
• Collaborate with vendors for solutions and compatibility reviews; develop custom assemblies if needed.
• Develop process flow diagrams, assembly drawings, and User Requirements Specifications.

Skills

Bachelors degree in Engineering

10+ years experience

Sterile pharmaceutical manufacturing

Vial/syringe filling

GMP knowledge

Engineering documentation

Education

Bachelor's degree in engineering

Tools

Single-use systems

Sterile filtration equipment

Job description

Actalent in Baltimore, MD is seeking a Senior Aseptic Process Engineer to lead evaluation, vendor collaboration, and implementation planning for aseptic process improvements in a regulated manufacturing setting. The role requires deep experience with legacy aseptic filling operations, single-use systems, and GMP engineering to reduce open exposure and improve process robustness.

You will translate contamination risks into technical requirements, develop URS and process diagrams, and guide