Job Title: Lead Aseptic Processing Simulation Consultant (APS)
Location: Boston, MA - Onsite
Contract Duration: 12 - Months
Hours: No shift Pattern
Overview:
We are seeking an experienced Manufacturing Supervisor 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. The Lead will work closely with cross-functional teams to ensure successful project execution while providing technical guidance to a team of Subject Matter Experts (SMEs).
Key Responsibilities:
- Lead and manage the integration of new resources into established workflows, ensuring seamless collaboration with the client’s team.
- Oversee and 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.
- Provide technical leadership and guidance to a team of 3 SMEs, ensuring deliverables are met on time and to a high standard.
- Support sterilization validation activities and provide execution support for critical process equipment qualifications.
- Act as the primary point of contact for client stakeholders, ensuring project milestones are achieved and reporting progress regularly.
- 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.
- 5 - 8 years of experience in Validation within GMP pharmaceutical or biotechnology environments, with a focus on aseptic processing and single-use systems.
- Proven experience leading APS (Aseptic Processing Simulation) projects and managing cross-functional teams.
- 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.
Join Us:
If you're a proactive leader with a passion for aseptic process validation and technical excellence, we invite you to apply and contribute to this critical project.
