Head Of Operations Jobs in Waltham, MA

Entity: CSL Behring

Job Category: Engineering

Job Family: Automation

Job Type: Full Time

Location: Waltham, Massachusetts, United States

Employer Reference: R-275416

Position Purpose:

The Global Automation Engineering & Technology Head is accountable for defining and executing the enterprise strategy for GxP manufacturing and laboratory digital systems, including PCS, MES, OT Data Systems, and LIMS platforms. This role provides global lifecycle ownership, governance, and standards for platforms, data, and recipes across manufacturing and QC laboratories, ensuring harmonized, compliant, and future-ready operations. Acting as a Center of Excellence, the position establishes digital roadmaps, oversees Tier 1 project delivery and Tier 2/3 governance, and drives strategic partnerships with suppliers and platform providers. The role interfaces broadly across I&T, Operations, Technical Operations, Quality, and Data Analytics to enable an integrated, data-driven, and innovation-oriented digital ecosystem.

Reporting Relationships:

• Role that this position reports to: Global Head Engineering

• Role/s that report to this position:

  • Lab Systems Lead

  • Manufacturing Data Systems Lead

  • Automation Standards, Governance & AI Strategy

  • OT Partner Enablement

  • OT Innovation & Capital Delivery Lead

Main Responsibilities and Accountabilities:

Digital Manufacturing & QC Strategy and Roadmap (Operational Technology Domain)

• Define and execute the global Operational Technology (OT) strategy and roadmap for manufacturing and QC systems, ensuring alignment with I&T and business strategies.
• Advance paperless, recipe-driven, and data-integrated execution aligned to ISA-88/95 and Pharma 4.0 principles.
• Prioritize OT initiatives that enhance productivity, regulatory compliance, and manufacturing reliability.
• Communicate OT strategy, value realization, and roadmap progress to executive and site leadership.

Enterprise OT Platform Lifecycle Ownership (DCS, MES, OT Data Systems, LIMS)

• Provide lifecycle ownership for Enterprise GxP manufacturing and lab OT platforms including OSI Pi, LIMS, Enterprise MES, Edge, Configuration management, and other enterprise tools
• Provider governance and decisioning on Automation Systems (DCS/SCADA), MES, etc.
• Ensure platforms meet operational, compliance, and performance standards across global sites.
• Drive harmonization and modernization of Enterprise OT platforms and support the roadmap for site integrations.

OT Governance, Compliance, and Architecture Leadership

• Lead enterprise OT governance structures (Design Authority, Standards Council, etc.).
• Define global OT standards for configuration, recipes, data, and cybersecurity in alignment with I&T, C&Q/CSV, GAMP 5 and GxP requirements.
• Maintain validated, secure, and interoperable architectures between plant-level systems and enterprise data layers.
• Ensure OT environments adhere to 21 CFR Part 11, Annex 11, and digital validation best practices.

OT Technology Deployment and Capital Project Oversight

• Accountable for Tier 1 capital project delivery for manufacturing and QC digital platforms.
• Govern Tier 2/3 site projects to ensure adherence to global OT standards, validation, and cybersecurity requirements.
• Manage readiness, commissioning, and hypercare for OT systems introduced via T1 capital or digital programs.

Organization / Center of Excellence Leadership and Team Development

• Lead the global OT organization encompassing Lab Systems, Data Systems, Recipe Standards, and Innovation & Partner Enablement.
• Operate as the OT Center of Excellence (CoE), defining best practices, playbooks, and training for site automation and lab teams.
• Build global OT capabilities, talent pipelines, and competency frameworks.
• Manage OT budgets (opex/capex) and resource allocation to maximize enterprise value.
• Place a high priority on developing others through coaching, feedback, and developmental goals.
• Provide a positive and equitable working environment, emphasizing values such as Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

Strategic OT Supplier and Platform Partnerships

• Develop and manage strategic partnerships with automation, MES, historian, and lab system platform provider (e.g., Siemens, Jag, Starlims, Aveeva (OSI) Pi).
• Develop and manage strategic partnerships with integrator partners (Mescada, CapG, Avacone, Cognizant, etc.)
• Align supplier roadmaps to OT strategy and ensure service excellence, cost optimization, and innovation delivery.
• Establish joint governance with system integrators (SIs) and solution providers for lifecycle performance.
• Leverage partner ecosystems to advance automation, edge computing, and digital manufacturing maturity.

Cross-Functional Collaboration and Operational Influence

• Collaborate closely with I&T, Operations, Technical Operations, Quality, Validation, and Data Analytics while retaining ownership of the OT domain.
• Ensure seamless data and integration flows between OT systems, enterprise layers, and cloud solutions under validated control.
• Influence global and site leaders to adopt standardized OT processes, architectures, and governance.
• Represent OT in enterprise risk, cybersecurity, and digital transformation forums.

Innovation and Emerging OT Technologies Enablement

• Identify and pilot emerging OT and industrial digital technologies (AI/ML at the edge, digital twins, composable MES, Cloud, etc.).
• Translate pilots into validated, scalable solutions that enhance reliability, compliance, and improve business outcomes.
• Embed advanced analytics and process optimization into OT platforms.
• Foster a culture of innovation and continuous improvement across the OT ecosystem.

Position Qualifications and Experience Requirements:

Education

• Bachelor of Science in an Engineering, Automation, Computer Science or local equivalent.

Experience

• 15+ years’ work experience, with at least 5 years’ experience in execution systems, operational technology, IT and operations
• Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95)
• Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, DCS, MES, PAT, LIMS, Digital Methods, OSI Pi Data historian, etc.) in a regulated large-scale process-based manufacturing environment.
• Experience in running site-based shop floor and laboratory systems in a globally distributed footprint is highly desirable
• A proven track record of influencing the industry on operational technology via publications and presentations is strongly preferred.
• Experience building, managing, and deploying high performing, innovative and transformational process automation / execution systems across a global organization.
• Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills
• Ability to build, mentor and grow a high performing and cohesive team
• Experience in Process Excellence methodology is desirable but not required.
• Ability to work across a range of countries and cultures
• Demonstrated experience in managing leaders, employees, and cross-functional project teams.
• Strong project management skills and experience in engineering projects within biopharma manufacturing.
• Functional knowledge of cGMPs and manufacturing operations in FDA-regulated facilities.

Competencies

• Automation & Execution Systems Expertise
• Project Management
• Regulatory Compliance
• Team Leadership & Development
• Strategic Planning
• Continuous Improvement & Innovation
• Stakeholder Engagement
• Strategic innovation
• Delivering Enterprise Results and Value Orientation