Sr. Engineer, Systems Integration (Quality Control)

Axogen•Vandalia, OH

About The Position

The Sr. Engineer, Systems Integration plays a pivotal role in driving continuous improvement, digital and automation transformation, and cross-functional collaboration within a regulated pharmaceutical manufacturing environment. This hybrid role bridges frontline operations with strategic initiatives, leveraging Lean methodologies, automated system platforms (especially Tulip), and stakeholder engagement to deliver scalable, compliant, and people-centered solutions.

Requirements

Bachelor’s degree in engineering or related science discipline with 5+ years’ related experience OR Master’s Degree in engineering or related science discipline and 2+ years’ related experience
A Minimum of 2 years’ experience in a Quality Control Lab, manufacturing, process design engineering, process optimization, or process development, within a GXP regulated environment (medical device, biologics, or pharmaceutical).
Advanced Smartsheet proficiency preferred.
Current understanding of Axogen processes preferred.
Strong technical writing and presentation skills.
Experience with SQL, Python, Power BI, and RESTful APIs a plus.
Lean Six Sigma certification, value stream mapping, and process controls experience all preferred.
Hands-on experience with Tulip, automation or similar low-code platforms preferred.
Willingness to handle human/animal tissue-based products.
Travel up to 20% may be required.
Strong understanding of Lean manufacturing, process validation, and compliance frameworks.
Experience leading cross-functional teams and managing complex projects from concept to deployment.
Excellent communication and stakeholder management skills across technical and non-technical audiences.
Familiarity with IT/OT architecture, IoT applications, and system integration strategies.
Proficiency in Excel, data analysis, and structured problem-solving methodologies.

Responsibilities

Plans, leads, and executes complex cross-functional projects that impact operations, manufacturing and broader business functions.
Drives multiple initiatives to completion with internal teams, external partners, and process customers, ensuring alignment, accountability, and measurable outcomes.
Supports operations and manufacturing goals by coordinating deliverables, timelines, and stakeholder engagement across functions.
Leads the implementation of automated processes—including development, equipment/process validations, specification creation, and cross-functional training.
Supports the validation lifecycle for new and modified automations, ensuring regulatory compliance and performance readiness.
Develops and sustains support systems for production workflows, enabling consistency, usability, and continuous improvement.
Facilitates integration of new business processes into existing operational frameworks, bridging technical requirements with scalable solutions.
Facilitates a consistent design methodology and standards for frontline process automations.
Partners with MES vendor engineering team(s) to scope and co-develop platform features that address real-world operational challenges.
Research device and system integrations, identifying optimal strategies for connecting equipment and systems to the MES platform.
Conducts interviews, data collection, and research to generate actionable insights for solution design and deployment.
Executes software validations and qualifications within respective departments.
Designs and implements inspection, testing, and evaluation procedures to ensure product acceptability and regulatory alignment.
Ensures all solutions and processes comply with strategic direction, quality standards, and regulatory requirements.