Automation Strategic Operations Manager (Biotech)
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want you to be part of.
The Automation Strategic Operations Manager is responsible for driving standardization throughout the Automation Engineering department, which encompasses Controls/Automation, MES Engineering, OT and the Automation Tech Services (Helpdesk) group. This role is also responsible for overseeing compliance, MES/Automation scheduling, recipe and automation development, GMP readiness, project development and execution, training, and driving continuous improvements. This role ensures seamless coordination and execution across multiple disciplines to support manufacturing operations.
Key Responsibilities:
Lead and manage relevant engineering projects, ensuring alignment with strategic objectives and operational needs.
Serve as an advisor to managers, team members, and cross-functional groups to meet project deadlines and resolve technical challenges.
Provide ongoing technical support for manufacturing automation systems and ensure continuous operational efficiency.
Act as a Subject Matter Expert (SME) in multiple disciplines of automation, providing technical guidance and writing validation documents, testing documentation, and Standard Operating Procedures (SOPs).
Ensure development and maintenance of comprehensive standard project schedules, including MES/documentation timelines, to ensure tech transfer and campaign readiness.
Balance multiple competing priorities, ensuring all tasks are completed on schedule. Proactively raise concerns regarding potential schedule delays before delivery dates are impacted.
Develop and prepare project documentation, including goals, scope of work, justifications, design deliverables, change control documentation, and cost estimates, as needed.
Support leadership in resource load planning and allocation for successful project execution.
Collaborate with global and CAPEX teams to ensure harmonization of processes and best practices across regions.
Preferred Qualifications:
Bachelors of Science in Engineering or related STEM field (Required).
10+ years experience in Pharma/Biotech (or equivalent industrial automation).
Proven experience in MES/Automation, project management, and engineering operations.
Strong technical writing skills, with the ability to create comprehensive documentation, including SOPs and Functional Specifications.
Expertise in manufacturing systems, automation, and continuous improvement ,practices.
Ability to manage multiple projects simultaneously, balancing priorities and deadlines.
Excellent problem-solving and communication skills, with the ability to advise and guide cross-functional teams.
Demonstrated leadership ability and supervisory experience, especially in automation or engineering groups.
Familiarity with CAPA processes, change control management, and regulatory compliance requirements.
Key Accountabilities:
Scheduling & Coordination Lead: Plan, manage, and oversee the execution of deliverables related to tech transfers, pre-campaign efforts, and continuous process improvements.
Information Gathering & Problem Identification: Secure relevant information, identify key issues, and assess relationships between different project components and teams to facilitate problem resolution.
Project Team Collaboration: Actively participate in Integrated Project Team (IPT) and Joint Project Team (JPT) meetings, as well as other meetings as the automation representative, to ensure alignment with project goals.
Audit & Inspection Participation: Serve as the automation Subject Matter Expert (SME) during audits and inspections, ensuring compliance with GMP and regulatory standards.
CAPA Ownership: Own and execute the completion of Corrective and Preventive Actions (CAPA), ensuring timely and effective resolution of identified issues.
Change Control Management: Initiate and oversee change controls, participating in all aspects of the change control process to maintain compliance and operational integrity.
Documentation Review & Updates: Review and update SOPs, Functional Specifications, and work instructions to ensure they meet regulatory and operational requirements.
CAPEX & Tech Transfer Coordination: Interface with CAPEX and tech transfer teams to ensure on-time delivery of automation systems, while adhering to industry best practices and project timelines.
Safety & Training Compliance: Perform all work in accordance with safety standards and meet all required training and certification requirements.
Supervisory Responsibilities: Perform in a supervisory role when required, leading the automation team to successfully execute project tasks and deliverables.
Other Duties: Perform additional tasks and duties as assigned to meet organizational needs and project requirements.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
