Engineer II, Process Validation

Danaher•Fargo, ND

7d•Onsite

About The Position

Aldevron, a Danaher operating company, is seeking an Engineer II, Process Validation to lead and support internal and external validation projects that enable the commercialization of life-saving medicines. This role is part of the Technical Operations Department and is an on-site position in Fargo, ND. The company is a world-class CDMO focused on accelerating the development of groundbreaking therapies and being the engine of innovation for genomic medicine pioneers. The position offers the opportunity to impact millions of lives by advancing science and unlocking human potential.

Requirements

Bachelor’s or master’s degree in engineering with 2+ years of experience.
Prior experience in leading deliverables across all three stages of process validation in biologics/small and large molecules manufacturing train with a thorough understanding of the manufacturing process.
Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices.
Proficiency in technical writing with deviation investigations, root cause analysis, and risk assessments.
Ability to travel 5% of the time to support audits and client visits.
Ability to lift, move or carry equipment up to 10 lbs.

Nice To Haves

Client facing roles such as prior experience in a CDMO environment
Sterile fill-finish process and equipment qualifications

Responsibilities

Design, execute, analyze, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning critical starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and lifecycle approach.
Drive risk-based approaches using tools such as pFMEA, risk ranking, and criticality assessments.
Apply statistical tools to evaluate process performance, including but not limited to process capability, trend analysis and control charts and DOE interpretation.
Serve as a technical SME for process validation with external clients, across internal teams such as MSAT, manufacturing, QC, QA and RA, and during client audits and regulatory inspections, kaizens and workshop events.