Process Specialist

Maryland

ABIO Process Specialist

Maryland

ABIO, LLC is seeking candidates for its Process Specialist role to support projects in the Maryland area.

The ABIO difference is driven by our hands-on capital project experience combined with process expertise. The core of our service is formed by the Process Specialists that focus on developing project execution strategies for complex technical projects.  As leaders within the organization, Process Specialists can make an impact at the cutting-edge of the biopharma industry.

Position Description

The Process Specialist has a thorough understanding of the implementation of facility and equipment for biopharmaceutical manufacturing processes through all project phases, sizes, and levels of complexity for the life sciences industry

Apply process expertise and capital project execution experience to develop project strategies and execution plans ranging across multiple production modalities (microbial, mammalian, gene and cell therapy)  

Responsibility to oversee the production of deliverables or lead activities which require more experience, deeper understanding or involve more complexity such as:

  • Site Selection
  • Project programming
  • Engineering design oversight and design review
  • Facility layout development
  • Vendor management and oversight
  • Automation development and execution strategy
  • Capacity planning / Expansion strategy
  • Risk assessments
  • Commissioning, qualification, and validation strategies

Conduct quality checks of documents for project deliverables, e.g., technical verification of design calculations and documentation, and drive overall project quality

Coordinate with internal and external parties, manage multiple complex tasks, establish priorities, and direct the work of others

Interface with client senior management and external partners, as required

Interface with ABIO Project Managers to develop proposals, focused on scope, man-hour planning, and scheduling

Lead and provide mentorship to junior engineers

Minimum Requirements/ Qualifications

  • BS or higher in engineering or life sciences
  • Experience with GMP manufacturing facility design considerations
  • Experience with specialized pharmaceutical process equipment: design, commissioning, qualifications, operation, or maintenance
  • Experience with automation strategies for clinical and commercial biopharma manufacturing
  • Knowledgeable in GMPs and industry regulations
  • Knowledgeable in ASME BPE, ISPE guidance for facility and process piping design
  • Project management experience including implementation of change controls in GMP facilities
  • Subject Matter Expertise in at least one area of biopharma manufacturing
  • Experience with multiple biopharma modalities (cell therapy, gene therapy, mAbs, vaccines, etc.)
  • Experience with deviation / nonconformance management
  • Experience with batch record and SOP development

Ready to Apply? Please submit resumes to hr@a-bio.com