Job Description:
Our client is seeking an experienced Project Manager (PM) with expertise in aseptic/sterile fill qualification to support a major initiative involving three prefilled syringe lines and one automated visual inspection machine. The PM will provide structure, coordination, and oversight across multiple workstreams to keep qualification efforts on schedule and ensure documentation is properly executed. The role requires strong Smartsheet proficiency.
Key Responsibilities:
- Lead and coordinate qualification activities for aseptic fill lines, inspection systems, and packaging equipment.
- Ensure execution and prioritization of qualification documents to move projects through critical approval gates.
- Drive project timelines and deliverables using Smartsheet and other project tools.
- Collaborate with engineers (many of whom are early in their careers or new to the company) to ensure proper completion of validation/qualification documents.
- Act as the central PM point-of-contact for facility-based efforts related to isolator fillers (Bausch+Ströbel), automated inspection, and integration into the aseptic filling suite.
- Interface with team members on automated warehouse and packaging line implementation efforts.
- Provide guidance in GMP environments, especially around aseptic processes, documentation, and compliance expectations.
- Help triage priorities based on project status, available inputs, and qualification dependencies.
Required Experience & Skills:
- 5+ years of Project Management experience in the pharmaceutical or biotech industry
- Strong background in sterile/aseptic fill operations and commissioning & qualification (C&Q)
- Proficient in Smartsheet for project tracking, documentation coordination, and team collaboration
- Familiarity with automated packaging equipment and visual inspection systems
- Ability to interpret qualification protocols and understand documentation flow
- Strong organizational and interpersonal skills – capable of “herding cats” and keeping team members focused on what matters
- Understanding of isolator filler systems (e.g., Bausch+Ströbel) and integration into cleanroom environments
Nice to Have:
- Experience with tech transfer processes
- Familiarity with automated warehouse systems
- Experience coordinating with cross-functional teams during facility startups
NC: Aseptic Fill & Qualification (SmartSheets) (237105)
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