Hologic - Remediation
Led Remediation Initiative Production Process Controls
Led Remediation Activities for 17 production lines
HOW WE HELPED
- Screened, interviewed and hired a 10 Sr. Engineers across Validation. Quality and Manufacturing.
- Managed a team of 10 senior engineers through weekly staff meetings and 1:1s to drive alignment on remediation progress.
- Standardized process flows and pFMEA’s across all lines for audit ready
- Led pFMEA Blitz model: 4 pFMEA’s completed in 2 sessions, 1 month
- Defined CTQs and assessed process/equipment validation gaps against regulatory requirements
- Extended Blitz model to revalidation activities for equipment’s and processes: 4 MVP completed in one Blitz
- Handed off to PM and engineering team for a sustainable execution and weekly reporting model.
Team Leadership
10 Sr Eng
pFMEA
6 completed
Validation Plan
4
Get in touch
Ready to partner with us ?
Let’s work together to transform your operations, empower your teams, and deliver tangible results.
