ŞEYMA Yılmaz
Manufacturing & Supply Chain Systems Associate Manager | Validation Lead | MES & UMC Expert | CSV Specialist
Istanbul
Summary
Dedicated and results-driven Validation Lead and Manufacturing Systems Specialist with over 9 years of progressive experience in the pharmaceutical industry. Skilled in Computer System Validation (CSV), equipment qualification, process validation, and GMP-regulated documentation. Proven success in leading validation and testing activities for large-scale digitalization projects, including MES implementations (Werum PAS-X, PharmaSuite) and Siemens UMC rollouts. Demonstrated ability to operate effectively in both Agile and traditional project frameworks. Highly competent in managing cross-functional teams, communicating with QA and stakeholders, and ensuring compliance with FDA, EU GMP, ISPE, and GAMP 5 requirements.
Overview
9
9
years of professional experience
13
13
years of post-secondary education
1
1
Certification
2
2
Languages
Work History
Associate Manager, Manufacturing & Supply Chain Systems
Accenture Industry X
12.2020 - Current
- Act as Validation Lead and Test Manager for Novo Nordisk global digital transformation programs (MES & UMC).
- Lead end-to-end validation lifecycle: URS gathering, risk assessments, protocol creation, execution, and reporting.
- Collaborate with QA and IT Compliance for audit readiness, deviation closure, and final approval.
- Supervise test execution across multiple sites and environments (validation, production).
- Support Siemens UMC implementation as Validation SME, contributing to both technical installation and CSV deliverables.
- Design and implement IOV strategies in line with Configuration Specifications and QA expectations.
- Prepare ITRA, Implementation Plan/Report (IMPP/IMPR), and support training rollout for new systems.
- Mentored and supported [Number] [Type] department employees to create strong workplace culture.
Qualification and Validation Specialist
Gensenta (Mustafa Nevzat) / Amgen Biotechnology Inc.
08.2018 - 11.2020
- Qualified and validated pharmaceutical systems and utilities including cleanrooms, HVAC, autoclaves.
- Conducted room qualification and environmental monitoring through HEPA filter testing, airflow pattern analysis, and temperature/humidity mapping.
- Led validation for equipment such as biosafety cabinets, RABS, lyophilizers, and laminar flow stations.
- Authored and updated SOPs per FDA, GMP, ISPE, ISO 22716 guidelines.
- Managed equipment lifecycle from commissioning to decommissioning; documented results and prepared final reports.
Production Engineer & Technical Writer
Gensenta (Mustafa Nevzat) / Amgen Biotechnology Inc.
08.2016 - 08.2018
- Authored Master Batch Records (MBRs), SOPs, and user manuals for sterile injectable (vial/ampoule) production.
- Participated in aseptic area upgrade projects: RABS, lyophilizer, semi-automatic loaders/unloaders.
- Conducted deviation investigations, root cause analysis, and implemented CAPAs.
- Prepared documentation for equipment validation (FAT, SAT, URS, IQ/OQ).
- Supported QA in document lifecycle control and change implementation via QMex.
Education
Master of Science - Engineering Management
Marmara University
01.2018 - 01.2019
Bachelor of Science - Chemical Engineering
Beykent University
01.2011 - 01.2015
Management Engineering - Double Major
Beykent University
01.2012 - 01.2016
High School Diploma - Science-Mathematics Track
Turgutalp Anatolian High School
01.2006 - 01.2010
Skills
MES (Werum PAS-X, PharmaSuite)
Siemens UMC
QMex
Azure DevOps
Jira
SAP
CSV
IQ/OQ/PQ
Test Plans/Reports
Protocol Development
URS/FAT/SAT
ITRA
GxP
FDA 21 CFR Part 11
EU Annex 11
GAMP 5
ISO/IEC 17025
GMP/GLP
Interests
Basketball
Swimming
Tango
Pilates
Fitness
Pastry & Cookie Baking
Remote Global Work Preference
Seeking remote, freelance, or hybrid roles in Computer System Validation, MES implementation, GMP compliance, and digital transformation within the life sciences sector. Highly effective in international teams and virtual collaboration environments (Teams, Zoom, SharePoint, Confluence).
Driving License
B, 01/01/14
Personal Information
Nationality: Turkish
Certifications Trainings
- Certified Scrum Master, with hands-on Agile experience
- GMP, GLP, ISO 22716, ISO/IEC 17025, TSC Academy, 2013
- Root Cause Analysis Training, Amgen, 2017
- Mini-MBA Programme, UNIVERIST Education, 2016
- Sales & Marketing Trainings, Bemar Career School, 2015
- Advanced MS Excel & Data Analysis, Udemy
Certification
Scrum master
Timeline
Associate Manager, Manufacturing & Supply Chain Systems
Accenture Industry X
12.2020 - Current
Qualification and Validation Specialist
Gensenta (Mustafa Nevzat) / Amgen Biotechnology Inc.
08.2018 - 11.2020
Master of Science - Engineering Management
Marmara University
01.2018 - 01.2019
Production Engineer & Technical Writer
Gensenta (Mustafa Nevzat) / Amgen Biotechnology Inc.
08.2016 - 08.2018
Management Engineering - Double Major
Beykent University
01.2012 - 01.2016
Bachelor of Science - Chemical Engineering
Beykent University
01.2011 - 01.2015
High School Diploma - Science-Mathematics Track
Turgutalp Anatolian High School
01.2006 - 01.2010