Sarah Lynch
Thun
Summary
Detail-orientated CQV Engineer with seven years of experience in the pharmaceutical and life sciences industries. Specializes in equipment qualification, regulatory compliance and process validation. Proven track record in project management having led and delivered both manufacturing and lab projects. Confident collaborating with cross-functional teams to ensure efficient, compliant and high quality project delivery. A team player that thrives in a fast-paced environment. Self-motivated and eager to undertake new challenges.
Overview
7
7
years of professional experience
1
1
Certification
Work History
CQV Engineer
Lonza
Visp
03.2024 - Current
- Lab and small equipment CQV engineer responsible for the commissioning and qualification of 30 families of systems
- Collaborate on the Lab and small equipment qualification strategy development
- Generate and execute DQ, IOQ, and COM protocols.
- Complete qualification documentation, FMEA, CFR and QFR
- Collaborate with CSV on the qualification of CSV lab equipment
- Temperature mapping and qualification of CTCs (fridges and freezers)
- Co-ordinate with vendors and contractors for equipment commissioning and troubleshooting
- Provide technical support following system handover to plant engineering and operations
Senior CQV Engineer
(CAI) Alexion
Dublin
12.2022 - 03.2024
- CQV Engineer for QC Laboratory Equipment Qualifications
- Project manage CAI scope of work and staff augmentation projects at Alexion
- LabChip GXII Touch HT SME
- Endosafe Nexgen-PTS Qualification
- CSV - Windows 10 upgrade project, core team member
- Data integrity Assessments
- 21 CFR P11 and Annex 11 Assessments
- Vendor Management
- Requirement Traceability Matrix generation
- Data Migration
- IQOQ protocol generation and execution
Supervisor GMP Manufacturing
StemCell technologies
Vancouver
01.2020 - 09.2022
- Generate Production Schedule and staff schedule
- Equipment qualifications (DARA filling system, RoSSFill, Parts Washer, Label Machine, Fridge and Freezer)
- Deviation management, CAPA implementation and SCARs
- Risk Assessments
- EHS and Safety Representative
- SOP generation
- Provide Aseptic training to the team
- Process Validation for NPIs and APS campaigns
QC ANALYST
Regeneron Pharmaceuticals
Limerick
05.2018 - 06.2019
- Environmental monitoring including non- viable particulate, viable air particulate, surface sampling, water, compressed gas and clean steam
- Conduct laboratory investigations and generate reports in response to invalid assays, OOS/OOT and deviations
- EMPQ for ISO 5, ISO 7 and ISO 8 process areas along with associated gas and water sampling points
- Track maintenance work/calibration of equipment using Bluemountain
- Safety walk-downs
- Consumable stock ordering
- Provide training other team members
Education
BSc - Biotechnology
NUIG
05-2018
Skills
- Commissioning, Qualification and Validation
- KNEAT, Power User
- DeltaV
- ValGenesis
- Protocol Generation and Execution
- Risk Assessment
- Change Control
- Deviation Management
- Data Integrity
- Root-cause analysis
- Project Management
- Aseptic Technique
- SAP
- LIMS
- Trackwise
- Lean methodologies
Certification
- Diploma, Project Management, UCD
- Diploma, French, Chambre de Commerce et d’industrie de Paris
- White Belt, Lean Sigma Quality, ATU
Professional Highlights
- Complete scope of work on the Lab and small equipment team, Project ORCA.
- Project manage the CAI/Alexion QC Lab Project (staff augmentation and SOW).
- Contribute to the successful EMPQ of two production lines.
- Core Team member for Alexion QC Lab Windows 10 upgrade/remediation project.
- Managing direct reports and maintaining strong working relationships.
- Successfully participate in both regulatory and internal audits.
- 2 years spent as Safety Representative.
Timeline
CQV Engineer
Lonza
03.2024 - Current
Senior CQV Engineer
(CAI) Alexion
12.2022 - 03.2024
Supervisor GMP Manufacturing
StemCell technologies
01.2020 - 09.2022
QC ANALYST
Regeneron Pharmaceuticals
05.2018 - 06.2019
BSc - Biotechnology
NUIG
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