Jonathon Mihu
Wendell,NC
Summary
Validation Engineer with 11 years of experience in the Pharmacetical Industry. Very technically proficient, with a multitude of experience in Validation, including Upstream and Downstream Processing, Computer System Validation, Sterile and Aseptic Filling, Utilities and Lab Systems.
Overview
12
12
years of professional experience
Work History
Senior Validation Engineer
Arcadis
05.2025 - Current
- Completed Equipment Commissioning and Qualification activities for a variety of production equipment for the onboarding of a new drug product.
- Assisted in Commissioning Activities for a 500L Bioreactor, Sartorius 500L Tangential Flow Filtration (TFF) Skid and a 200L Chromatography System. Commissioning Activities included initial equipment setup and troubleshooting, DeltaV recipe sequence development and system P+ID walk-downs.
- Performed Qualification Activities for the 500L Bioreactor, 500L TFF Skid, 200L Chromatography Skid, Benchtop KR2i System, VeriPac CCIT, instrument air drops and site WFI System. Qualification entailed both Equipment IOPQs and CSV IOQs.
- Qualified changes to the DeltaV system, including Parameter and Configuration Updates, Recipe Sequence of Operations Testing, and equipment recipe troubleshooting.
Validation Engineer III
Resilience
05.2022 - 03.2025
- Responsible for Qualification of new and existing equipment, including Temperature-Controlled Units, Autoclaves and Bioreactors. Involved in all phases of the Validation Lifecycle, including initial User Requirement Specification (URS) reviews, authoring protocols in compliance with site procedures and regulatory requirements, physical execution, final report drafting and periodic Quality Reviews.
- Assisted in the review and development of Standard Operating Procedures, Work Instructions and Technical Specifications using technical and regulatory expertise.
- Key Accomplishments include successful qualification of 15 Liquid Nitrogen and -80C Freezers, completion of over 100 Equipment Quality Reviews and Instrument Performance Verifications, presenting qualification reports for a successful FDA Pre-Approval Inspection, on-boarding and qualification of the Kaye ValProbe RT System and becoming a trained risk assessment facilitator.
Validation Specialist II
Grifols Therapeutics
10.2019 - 05.2022
- Participated in the commissioning and initial qualification of equipment in a newly built Fractionation building. Authored and executed qualification protocols for over 20 pieces of equipment, including Cleaning Validation for Tanks, Filter Presses and Chromatography Skids, as well as Sequence of Operations verification for Sterilize-in-Place (SIP) and Filtration Skids.
- Responsible for Validation activities on existing equipment in the facility, including temperature mapping of Aseptic Autoclave Loads and SIP systems, steam quality testing and equipment periodic review.
- Executed monthly cleaning studies for the Continued Cleaning Validation program.
- Performed temperature mapping in all areas of the facility, including Temperature-Controlled Units (TCUs), controlled storage areas, walk-in freezer rooms and seasonal mapping for storage warehouses.
Senior Validation Engineer
Pfizer
08.2014 - 10.2019
- Responsible for supervising 3 Validation Technicians performing annual requalifications in the Compliance Validation Department. Successfully completed over 100 requalifications on filling equipment, including scheduling production downtown, authoring the validation protocol, and post-execution review and approval.
- Responsible for performing the Validation section of the Annual Product Quality Review (APQR) for various products across all site business units.
- Subject Matter Expert (SME) on a variety of both Aseptic and Terminal Sterilization (TS) filling equipment, including Autoclaves, Depyrogenation Ovens and Tunnels, Parts and Commodity Washers and Vaporized Hydrogen Peroxide (VHP) isolators. Prepared and presented Validation packages as the SME for regulatory and client audits.
- Authored a major risk assessment to formally document the requalification frequency of all equipment types across site. Saved production downtime by reducing the requalification frequency of less-critical equipment, and improved compliance by identifying gaps in the existing requalification program.
- Gained extensive experience with a variety of both manufacturing and laboratory equipment, including Autoclaves, Depyrogenation Ovens and Tunnels, Commodity Washers and Vaporized Hydrogen Peroxide (VHP) isolators.
- Informed management of any out-of-specification result and help to investigate the true root cause of events. Involved in multiple high-level investigations for deviations as the equipment SME.
Education
Bachelor of Science - Chemical Engineering
North Carolina State University
05-2014
Skills
- IOPQ and Requalification
- Protocol and Final Report Drafting
- Equipment Commissioning and Troubleshooting
- DeltaV Recipe and Configuration Testing
- Risk Assessment Authoring and Facilitation
- Controlled Document (SOP, URS, FRS) Updates
- Technical Drawing Verification (PID Walkdowns)
- Validation Data Review
- Cleaning Validation
- Aseptic and Terminal Sterilization Processing
- Validation Plans
- Single-Use Processing Equipment
Timeline
Senior Validation Engineer
Arcadis
05.2025 - Current
Validation Engineer III
Resilience
05.2022 - 03.2025
Validation Specialist II
Grifols Therapeutics
10.2019 - 05.2022
Senior Validation Engineer
Pfizer
08.2014 - 10.2019
Bachelor of Science - Chemical Engineering
North Carolina State University