Ann-Rikka Søgaard

Senior process Engineer

GMP | Project management | Technology

Summary

Ann-Rikka has 18 years of experience in the pharmaceutical industry. Working in Novo Nordisk A/S at a fermentation and recovery Pilot plant with hands on operation of the equipment and also reporting. Then Black utility, Clean Utility, distillation and freeze drying in purification plants. Latest working with recovery, clean utility, RVS and distillation in a recovery plant. She has a wide range of competences working with daily production, process equipment, changes and validation, optimization and project lead, where she has been responsible for:

Deviations and systematic problem-solving
Change request, with or without regulatory impact
Risk evaluations: QRM, CARA, FMECA, EHS, OHS
Numerous validations setups and experienced Engineering Responsible and
Operation Responsible
Requirement setting for new processes or equipment
Verification steps as DQ, FAT, SAT, IV, OV, testing and PFV • SME on regenerated ethanol and clean utility.

Special Competences

Project management: Either as primary user at big project or project leader for numerous smaller project (<6 employees)
Technology: Experienced in working with a wide range of unit operations and processes such as distillations columns, clean steam, nitrogen, process air, process water, purified water, centrifuges, capture columns, crystallization and dynamic crossflow filter, RMS, fermentation, CIP, sterilization, solvent mixing, sampling, autoclaves and black utility.
GMP: Prepare and execute documentation fulfilling EU (EudraLex) and US (FDA) requirements to Qualification and Validation
Personal: Open minded, Capable of maintaining overview and cut to the chase, quick learner, proactive, solution oriented and with a can-do attitude. Always helpful and positive.

Project Experience

New line for insulin recovery, OR on regenerated ethanol package. Requirement setting, evaluation of risk, design of the new equipment and functionalities.
Novo Nordisk A/S, Denmark – 2022