Staff Process Engineer

Responsibilities

• Translate client needs into requirements and project plans
• Responsible for technology transfer activities at the site level (within, inbound, and outbound), including any scale-up or other process adaptations
• Lead and/or support late stage process development activities including characterization, comparability, and qualification/validation activities
• Own the technology transfer from Process Development to cGMP Manufacturing operations - author the change record, draft/review/approve SOPs and batch records, train manufacturing personnel
• Support development of manufacturing operations and business processes, including GMP system implementation and tasks related to GMP readiness
• Support labor and equipment capacity modeling and participate in sales and operations planning process (S&OP) for supply review
• Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies
• Provide user needs, requirements, and support implementation and UAT of Cellares software solutions (in-house or enterprise)
• Own root cause investigations and train manufacturing personnel to support robust root cause analysis. Facilitate complex cross-functional investigations
• Propose and implement corrective and preventive actions (CAPAs) as necessary and own respective effectiveness checks to ensure recurrence was prevented
• Facilitate and/or own the generation of process or operational-related Failure Modes and Effects Analysis (FMEA) and resulting mitigations and actions
• Develop training and onboarding content and curriculum for new hires and new methods
• Maintain and report process run summaries and continued process verification reports
• Prepare and present data associated with manufacturing processes to internal and external partners, as well as health authority inspectors
• Support for process qualification and validation preparation, execution, monitoring, and reporting
• Work with clients on process mapping of the manufacturing processes

Requirements

• Bachelor’s Degree in a scientific or related field is required
• A minimum of 11+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
• Experience with technology transfer in the Pharma/Biotech industry 
• Must have experience writing and reviewing GMP documentation
• Strong analytical, problem-solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
• Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organization
• Experience with Operational Excellence and/or Lean Manufacturing is a plus
• Excellent planning, organization, technical writing, and time-management skills, including the ability to support, problem-solve, and prioritize multiple projects and deadlines