Today, Lonza is a global leader in life sciences operating across three 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 to be part of.
The Manager Project Engineering at Lonza AG is an outstanding opportunity to lead ambitious projects with a global impact. This role is crafted for those who are passionate about driving continuous improvement and operational efficiency within a world-class organization. You will be at the forefront of innovation, working to successfully implement projects that craft the future of our site’s capabilities!
Key responsibilities:
Project Execution and Management:
Coordinate assigned projects through all phases, including conceptual design, detailed design, equipment procurement, construction, installation, start-up, commissioning, qualification, and handover.
Ensure that all project objectives are achieved in accordance with project scope, timelines, and budgets.
Collaborate with internal teams, external vendors, and contractors to ensure the seamless execution of projects, from design to final handover.
Scope, Schedule, and Budget Management:
Define project scope, deliverables, achievements, and timelines, ensuring alignment with organizational objectives.
Develop, manage, and optimize project schedules and budgets.
Provide regular and detailed status updates to leadership, highlighting progress, risks, and corrective actions.
Work closely with collaborators and internal team members to develop capital estimates, budgets, and timelines for large-scale projects.
Track and control project costs, providing regular financial reporting and forecasting to ensure alignment with approved budgets.
Contractor and Collaborator Coordination:
Manage relationships with key collaborators, ensuring clear communication and alignment throughout the project lifecycle.
Coordinate with internal teams and external contractors (including equipment manufacturers) to ensure smooth project execution.
Provide technical mentorship and encouragement to contractors, trades, and team members, nurturing a positive safety culture and ensuring compliance with industrial and GxP requirements.
Investigations and Documentation:
Lead investigations into equipment, utilities, and facility issues, using structured problem-solving techniques such as Root Cause Analysis (RCA).
Document investigation findings, root causes, corrective actions, and preventive measures.
Qualification Program Ownership:
Own and manage the site’s qualification program, ensuring that all applicable equipment, utilities, and facilities are maintained in a validated state.
Lead and coordinate periodic qualification reviews, requalification, and other assessments as necessary to ensure compliance with cGMP and other regulatory standards.
Ensure accurate documentation is maintained throughout the qualification lifecycle and is available for audits or internal reviews.
Managing and Developing Engineers:
Lead, mentor, and develop a team of engineers, providing technical mentorship and encouraging their growth within the organization.
Coordinate day-to-day operations of the engineering team, ensuring the successful execution of engineering projects while supporting individual development and performance.
Ensure that engineers are equipped with the necessary tools, training, and resources to perform their roles effectively, and provide opportunities for continuous learning and skills development.
Conduct regular performance reviews, identifying areas for improvement and crafting development plans to help engineers meet their career goals.
Promote a culture of collaboration, innovation, and continuous improvement within the engineering team.
Functional Competencies:
Proficient in creating clear, accurate, and detailed technical documentation for equipment procurement, design specifications, qualification protocols (IQ, OQ, PQ), process validation, safety procedures, and project reports.
Industry Knowledge:
Comprehensive understanding of FDA-regulated industry requirements and Good Manufacturing Practices (cGMP).
Technical Knowledge and Skills:
Hands-on experience with engineering software tools (e.g., AutoCAD, SolidWorks, PLC programming) and business systems (SAP, CMMS, CCMS, EAM) for managing equipment, assets, and project workflows.
Use structured methods like FMEA, Fishbone diagrams, and 5 Whys to find causes of issues in pharmaceutical manufacturing.
Deviation and Non-Conformance Management: Experienced in managing and documenting deviations and non-conformances in a GxP environment, ensuring proper investigation protocols are followed and compliance with cGMP. Ensures timely resolution and thorough reporting to meet regulatory standards.
Corrective and Preventive Action (CAPA): Skilled in developing, implementing, and following up on CAPA plans to address identified issues. Ensures corrective actions are effectively completed and preventive measures are implemented to avoid recurrence.
Data Integrity and Documentation: Strong understanding of maintaining the integrity of data throughout the investigation process. Ensures all findings are accurately documented in Deviations Reports, Investigation Records, adhering to 21 CFR Part 11 and other regulatory documentation requirements.
General Duties:
Project Scope and Management: Conduct comprehensive project scoping, including engineering design, cost estimation, scheduling, procurement, supervision, and construction management.
Project and Budget Management: Develop and manage project budgets, providing ongoing financial tracking, forecasting, and control.
Risk and Issue Management: Proactively identify project risks, advancing issues promptly, and proposing solutions to ensure project success.
Team Leadership: Lead and mentor the engineering team, ensuring alignment with project goals and providing development opportunities.
Documentation and Compliance: Ensure all project documentation meets regulatory compliance standards and is accessible for audits.
Qualification and Maintenance: Coordinate qualification activities for equipment, utilities, and facilities, ensuring compliance with industry standards.
Asset Management: Manage company assets within CMMS, CCMS, and EAM systems, ensuring proper tracking and documentation.
Procedure Development: Generate, revise, and provide training on SOPs, work instructions, and other technical documentation.
Administration: Maintain and update facility drawings and control documents as necessary.
Special Projects: Contribute to special studies, continuous improvement initiatives, and other tasks as needed.
Key requirements:
Bachelor's degree or equivalent experience in Engineering or a related field.
7+ years of experience managing complex engineering projects.
Strong understanding of pharmaceutical manufacturing processes.
Expertise in FDA-regulated industry requirements and Good Manufacturing Practices (cGMP).
Outstanding leadership and team management skills.
Excellent communication and interpersonal skills.
Proficiency with engineering software tools and business systems.
Strong problem-solving abilities and attention to detail.
Compensation for the role will depend on a number of factors, including the successful candidate’s qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
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.