Sr. Engineer, Systems Integration (Quality Control)

About This Role

This role is designed to advance continuous improvement, digital and automation transformation within a regulated pharmaceutical environment, integrating Lean methodologies and automated systems. This role bridges frontline operations with strategic initiatives, focusing on scalable, compliant, and people-centered solutions.

Responsibilities

• Plan, lead, and execute complex cross-functional projects impacting operations, manufacturing, and broader business functions.
• Drive multiple initiatives to completion with internal teams, external partners, and process customers, ensuring alignment, accountability, and measurable outcomes.
• Support operations and manufacturing goals by coordinating deliverables, timelines, and stakeholder engagement across functions.
• Lead the implementation of automated processes, including development, equipment/process validations, specification creation, and cross-functional training.
• Support the validation lifecycle for new and modified automations, ensuring regulatory compliance and performance readiness.
• Develop and sustain support systems for production workflows, enabling consistency, usability, and continuous improvement.
• Facilitate integration of new business processes into existing operational frameworks, bridging technical requirements with scalable solutions.
• Facilitate a consistent design methodology and standards for frontline process automations.
• Partner 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.
• Conduct interviews, data collection, and research to generate actionable insights for solution design and deployment.
• Execute software validations and qualifications within respective departments.
• Design and implement inspection, testing, and evaluation procedures to ensure product acceptability and regulatory alignment.
• Ensure all solutions and processes comply with strategic direction, quality standards, and regulatory requirements.

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).
• Strong technical writing and presentation skills.
• Willingness to handle human/animal tissue-based products.
• 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.
• Proficiency in Excel, data analysis, and structured problem-solving methodologies.

Qualifications

• Bachelor's degree in engineering or related science discipline OR Master's Degree in engineering or related science discipline
• 5+ years' related experience with a Bachelor's degree or 2+ years' related experience with a Master's degree. A minimum of 2 years' experience in a Quality Control Lab, manufacturing, process design engineering, process optimization, or process development.

Nice to Have

• Advanced Smartsheet proficiency
• Current understanding of Axogen processes
• Experience with SQL, Python, Power BI, and RESTful APIs
• Lean Six Sigma certification, value stream mapping, and process controls experience
• Hands-on experience with Tulip, automation or similar low-code platforms
• Familiarity with IT/OT architecture, IoT applications, and system integration strategies

Skills

* Required skills

Benefits