Position: Manager/Sr. Manager Process Validation & Analytics
Location: Durham NC
Full Time/Direct Hire
Process Validation and Analytics (PVA) Manager is responsible for establishing and maintaining the procedures, business processes and tools in support of the process validation program and process monitoring/analytics program at the Durham Manufacturing site. The PVA Manager will also manage a small team of Engineers and Scientists that serve on cross-functional Process Validation projects and support Manufacturing Sciences Process Leads in analyzing Manufacturing process data. PVA Manager should possess proven technical writing and strong knowledge of the industry guidance's related to process monitoring.
- Facilitate new commercial product introduction through Process Performance Qualification (PPQ) and maintain a Continuous Process Validation (CPV) program through a Pre-Approval Inspection (PAI).
- Ensure success by adhering to industry standards (FDA, PDA, ICH and BPOG guidance’s).
- Responsible for oversight of process validation and monitoring programs at the Durham Manufacturing site. The PVA group is responsible for establishing and maintaining the procedures, business processes and tools for process validation and process monitoring/analytics.
- Represents the department during audits, meetings, and teleconferences regarding process validation issues with Regulatory agencies and client auditors. Provides related responses to inspections and audit observations.
- Lead or support PVA staff leading multi-disciplinary process validation teams. Negotiates the scheduling and commitment of specific resources outside the department required for validation projects.
- Train and mentor a PVA staff and contractors in supporting PVA projects or process monitoring programs.
- Performs a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promoting, disciplining and firing. Identify opportunities and provide the means for employees to pursue career growth.
- BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience; 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices (cGMP) including: Validation, QA, Manufacturing or process engineering.
- Must have experience in enrolling commercial programs into PPQ and maintaining a validated state through CPV. Experience of a Pre-Approval Inspection (PAI) is a bonus.
- Thorough understanding of industry guidances (FDA, PDA, ICH and BPOG) and history of developing process validation protocols and authoring reports for a biologics process.