PhD Chemical Engineering · BSc Biological Engineering

Arda
Akyel

Bridging pharmaceutical validation, bioprocess engineering, and research — from bench-scale discovery to GMP manufacturing environments.

Portrait of Arda Akyel
100+
Protocols Authored
5
Peer-Reviewed Publications
180+
Scholar Citations
1
U.S. Patent
01

About

I'm a chemical engineer with a PhD from Montana State University and a career at the intersection of pharmaceutical validation, bioprocess engineering, and applied research. Currently at Arcadis, I lead commissioning, qualification, and validation efforts across greenfield biomanufacturing sites — qualifying complex process equipment from fill-finish to oligonucleotide synthesis.

Before industry, I spent seven years at the Center for Biofilm Engineering researching bacterial enzymatic biomineralization — using microorganisms to seal CO₂ leakage pathways in subsurface environments. That work resulted in five publications, a U.S. patent, and a large-scale field demonstration at a coal-fired power plant in Gorgas, Alabama.

My strongest asset is the ability to move fluidly between rigorous scientific thinking and real-world manufacturing constraints — whether drafting ASTM E2500 risk-based qualification strategies or optimizing enzyme kinetics under harsh pH and temperature conditions.

GMP Validation
Full lifecycle ownership from FAT through PQ. Regulatory fluency across 21 CFR Part 11, EU Annex 11/15, GAMP 5, and ASTM E2500.
Bioprocess Engineering
Hands-on with chromatography, ultrafiltration, CIP, bioreactors, and sterile processing — both at bench scale and in GMP environments.
Documentation & Communication
GDP-fluent author of validation protocols and peer-reviewed manuscripts — the same precision applied at both scales.
02

Experience

May 2022 – Present
Arcadis
Commissioning, Qualification & Validation Engineer II
Lead qualification and validation across three greenfield biomanufacturing sites, including a fill-finish facility. Authored and executed 100+ URS, IQ, OQ, and PQ protocols for complex process equipment — reactors, chromatography skids, ultrafiltration systems, CIP, and computer/automation systems — in compliance with GDP guidelines and internal quality standards. Lead GDP documentation teams of up to 10 engineers in fast-paced, high-stakes environments. Clients include Nitto Avecia (oligos CDMO), Resilience (multi-modality CDMO), and Eli Lilly. Validation platforms: Veeva, SmartSolve, Kneat.
IQ/OQ/PQ ASTM E2500 21 CFR Part 11 EU Annex 11/15 GAMP 5 GDP Fill-Finish Oligonucleotides Biologics
Feb. 2015 – Jul. 2022
Center for Biofilm Engineering
Research Assistant
Seven years of hands-on bioprocess work in a BSL-1/BSL-2 laboratory setting: aseptic and sterile technique, microbial cell culture, enzyme purification, lyophilization, and analytical method development (HPLC, spectrophotometry). Designed and ran kinetic studies on plant- and microbial-source ureases — characterizing enzyme stability across temperature, pH, and ionic strength — the same kind of process characterization mindset used to define and defend operating ranges in GMP. Authored five peer-reviewed publications and a U.S. patent, producing the rigorous, audit-grade documentation that translates directly into protocol and report writing. Contributed to a multi-year program that scaled bench science through pilot to field demonstration.
Aseptic Technique Enzyme Kinetics Cell Culture Lyophilization HPLC Process Characterization Scientific Writing Python MATLAB
03

Publications & Patent

2021
Key applications of biomineralization, Mineral formation by microorganisms: concepts and applications
The Microbiology Monographs — Akyel, Coburn, Phillips, Gerlach
2021
Ureolysis-induced calcium carbonate precipitation (UICP) in the presence of CO₂-affected brine: a field demonstration
International Journal of Greenhouse Gas Control — Kirkland, Akyel et al.
2020
Temperature-dependent inactivation and catalysis rates of plant-based ureases for engineered biomineralization
Engineering Reports — Akyel, Feder, Morasko, Gerlach, Phillips
2020
A Numerical Model for Enzymatically Induced Calcium Carbonate Precipitation
Applied Sciences — Hommel, Akyel et al.
2018
Facultative and Anaerobic Consortia of Ureolytic Microorganisms Capable of Precipitating Calcium Carbonate
Applied Microbiology — Skorupa, Akyel, Fields, Gerlach
§

U.S. Patent — Ureolysis-Induced Calcium Carbonate Precipitation for Sealing Channels and Other Uses

US20220169908A1

Novel biocementation technology for subsurface sealing applications. Developed from seven years of bench, pilot, and field-scale research.

04

Education & Certifications

Ph.D. in Chemical Engineering
Montana State University
Jan 2016 – Aug 2022
B.Sc. in Biological Engineering
Montana State University
Aug 2011 – May 2015

Certifications & Training

  • Lean Six Sigma White BeltAveta Business Institute
  • Managing Process Safety HazardsAIChE
  • Introduction to Process SafetyAIChE
  • Introduction to Managing Process Safety HazardsAIChE
  • Biosafety for BSL1 & BSL2 Lab WorkersCITI Program / BRANY
  • Hazard Communication — GHSOSHA
05

Skills & Expertise

Validation & Quality

  • IQ / OQ / PQ Authorship & Execution
  • URS / FRS Documentation
  • ASTM E2500 Risk-Based Validation
  • 21 CFR Part 11 Compliance
  • EU Annex 11 / Annex 15
  • GAMP 5
  • GDP / GMP
  • Deviation & Change Control
  • Veeva, SmartSolve, Kneat

Bioprocess & Engineering

  • Bioreactors & Reactor Design
  • Chromatography (Cytiva, Sartorius)
  • Ultrafiltration Skids (Pall)
  • CIP / SIP Systems
  • Sterile & Aseptic Technique
  • Lyophilization
  • Fill-Finish Processes
  • Upstream / Downstream Processing
  • Enzyme Kinetics

Research & Technical

  • Experimental Design
  • Microbiology & Cell Culture
  • Protein Purification
  • HPLC & Analytical Methods
  • Python & MATLAB
  • Scientific Writing
  • Technology Transfer
  • Team Leadership (up to 10)
  • Cross-functional Collaboration
06

Contact

Get in
touch.

For collaborations, inquiries, or to discuss validation, bioprocess, and research.