Job Title : SME Aseptic Process Engineer Consultant (APS)

Location : Boston, MA - Onsite

Contract Duration : 12 - Months

Hours: No shift Pattern

Overview :

We are seeking an experienced Manufacturing Engineer to support a high-priority Aseptic Processing Simulation (APS) project within a GMP manufacturing environment. The role will focus on driving APS execution, process improvements, and document revisions related to single-use systems and cell culture processes.

Key Responsibilities :

• Execute APS protocols for existing processes, ensuring compliance with regulatory and client-specific requirements.
• Revise and edit existing protocols, batch records, and other related documentation based on team feedback.
• Manage document compilation, ensuring accuracy and alignment with current GMP standards.
• Collaborate with cross-functional teams to troubleshoot issues related to aseptic processes, single-use systems, and cell culture workflows.
• Support sterilization validation activities and provide execution support for critical process equipment qualifications.
• Identify opportunities for process optimization and assist in implementing best practices to enhance efficiency and compliance.

Qualifications :

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3-5 years of experience in Validation within GMP pharmaceutical or biotechnology environments, with a focus on aseptic processing and single-use systems.
• Proven experience within APS (Aseptic Processing Simulation) projects.
• Strong expertise in cell culture processes and process equipment qualification.
• Exceptional document management skills, including the ability to edit and revise protocols, batch records, and CAPA documentation.
• Experience with sterilization validation and support for equipment qualification processes.
• Excellent communication and leadership skills, with the ability to manage multiple priorities and drive projects to completion.

Preferred :

• Experience supporting large-scale APS projects across multiple suites or production lines.
• Familiarity with regulatory standards and guidelines related to aseptic processing and single-use systems.