Lead Aseptic Processing Simulation Consultant

2 days ago

Boston, United States i-Pharm GxP Full time

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.

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