Clean utilities backbone qualified and handed over.
As Validation Lead and Work Package Owner, Damgaard Solutions owned WFI, clean steam, clean air, and nitrogen for the M1 aseptic facility at Novo Nordisk Maaloev, from URS through process validation under EU GMP Annex 1.
A Clean Utilities Package on the Critical Path
Project M1 added a new aseptic filling capability into an existing Novo Nordisk site at Måløv, a brownfield environment where new clean utilities had to integrate with a live facility. The package covered pre-treatment water, WFI, clean steam, clean air, and nitrogen, all on the critical path for a Grade C aseptic operation under EU GMP Annex 1 and Novo Nordisk site standards.
The work demanded end-to-end ownership, from requirements and design review through qualification and process validation, while the schedule itself shifted. Changing business requirements, resource constraints, and external dependencies forced several milestones to be rescheduled without compromising quality or compliance.
End-to-End Ownership as Validation Lead and Work Package Owner
Damgaard Solutions held the clean utilities package as Validation Lead and Work Package Owner, carrying technical and validation responsibility across the full delivery cycle.
1. Requirements and design authority
Authored the URS and Engineering Specifications for the clean utilities package, developed validation plans and risk assessments, and led design reviews including approval of P&IDs and functional specifications.
2. Supplier and construction oversight
Led supplier assessment and selection, acted as primary technical and mechanical engineering contact, and oversaw construction activities on site.
3. Qualification and process validation
Executed FAT, SAT, IQ, OQ, PQ, and process validation, and planned and facilitated IV/OV test execution including test plan creation, documentation review, and approval.
4. Schedule and risk control
Tracked external dependencies early, established clear ownership to prevent milestone slippage, ran more frequent risk assessment cycles, and escalated blockers early to protect both quality and the revised timeline.
Samsam Touranian is a Validation Lead and Work Package Owner at Damgaard Solutions, trusted to carry complex clean utilities and process validation scopes end to end. Working independently inside framework agreements, he makes well-founded technical decisions with minimal client oversight and keeps GMP delivery on pace under schedule pressure.