System Engineering Manager

Responsibilities

• Provide hands-on technical leadership in mechanical and electrical process automation, establishing engineering principles and applying technology to design, develop, document, install, qualify, and optimize automated diagnostic consumable manufacturing equipment, batch processing systems, and semi-finished reagent formulation systems.
• Provide indirect leadership across the broader Manufacturing Engineering and Facilities organization through project portfolio management, including prioritizing initiatives, aligning resources, strengthening governance, managing interdependencies, and driving execution of complex cross-functional projects and programs.
• Serve as a subject matter expert for applicable Quality System requirements, ensuring projects comply with user requirements, design controls, validation, risk management, documentation, and change management expectations while driving continuous improvement.
• Partner with internal stakeholders and external equipment suppliers to define requirements, resolve technical challenges, and implement robust, compliant, and maintainable process equipment solutions.
• Collaborate with Quality and Business Excellence organizations to establish and continuously improve standards and templates for equipment specifications, validation deliverables, change management documentation, and work instructions.
• Serve as the subject matter expert for capital procurement processes and partner with Procurement, Finance, and Legal to guide sourcing strategy, supplier selection, commercial alignment, contracting, purchase execution, and process compliance.
• Represent the Project Engineering team in internal and external Quality audits, providing authoritative guidance, ensuring inspection readiness, and leading timely resolution of audit observations.
• Provide routine off-hour process support for mechanical equipment issues, typically one week every 10 to 12 weeks, or as required.

Qualifications

• Significant hands-on automation engineering experience with formulation, filling, packaging, and related manufacturing processes and equipment.
• Demonstrated success as a working manager providing direct leadership, coaching, and development to multidisciplinary teams of engineers and technicians while remaining actively engaged in technical and project execution.
• Experience leading engineering project portfolios, including prioritizing initiatives, aligning resources, managing interdependencies, strengthening governance, and influencing cross-functional organizations without direct reporting authority.
• Extensive experience applying Quality System requirements in a regulated manufacturing environment, including user requirements, design controls, validation, risk management, change management, technical documentation, and audit readiness.
• Experience serving as a subject matter expert for capital procurement processes and partnering with Procurement, Finance, and Legal on sourcing strategy, supplier selection, commercial alignment, contracting, purchase execution, and process compliance.
• Experience partnering with internal stakeholders and external equipment suppliers to define requirements, develop scope and budgets, resolve technical challenges, and deliver robust, compliant, and maintainable equipment solutions.
• Strong interpersonal, written, and verbal communication skills, with the ability to build trusted relationships, influence decisions, and communicate effectively across technical teams, senior leadership, and external partners.
• Working knowledge of industrial automation technologies and principles, including operational technology networking, SCADA, batch control, computerized maintenance management systems, and manufacturing execution systems.

Skills Necessary for Success

• Bachelor's degree in Mechanical, Chemical, Electrical, or a related engineering discipline.
• 10 or more years of progressive experience delivering technical support and leading complex engineering projects within a cGMP-regulated manufacturing environment.
• Five or more years of demonstrated leadership experience, including direct team management and/or cross-functional influence.
• PMP or recognized Agile project management certification is preferred.
• Working knowledge of project portfolio management and data analytics platforms, including Microsoft Project and Power BI.
• Experience with Mechanical and Electrical design and documentation software.
• Experience with NX, Teamcenter PLM, SolidWorks, and/or AutoCAD preferred.
• Experience utilizing Lean methodologies such as TPM, 5S, Lean 3P Design, & OEE Monitoring.
• Demonstrated ability to lead and collaborate with technical and operational teams to drive results.
• Ability and willingness to travel up to 10% in support of business and project priorities.