Senior Manufacturing Project Specialist

United States, Portsmouth (New Hampshire)

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 dedicated 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

We are seeking a Senior Manufacturing Project Specialist to be a pivotal player in our midscale operations. This advanced-level position requires a strong blend of technical knowledge, quality background, and expert project management skills. You will be essential in driving site and departmental goals by working closely with Manufacturing, MSAT, Quality, and Engineering. This role is highly cross-functional and customer-facing, demanding strong leadership to execute strategic initiatives, manage high-impact projects, and ensure operational readiness and compliance.

Key Responsibilities

• Project Management Leadership: Lead and manage multiple medium-to-large-scale projects concurrently, overseeing their full lifecycle from planning through closure with minimal supervision.
• Strategic Execution & Campaign Readiness: Drive manufacturing preparedness for strategic initiatives, including tech transfers, process improvements, facility design changes, and procurement activities.
• Technical Subject Matter Expertise (SME): Act as the Subject Matter Expert (SME) for midscale operations, providing advanced technical support for process equipment design, operation, and the introduction of new analytical instruments.
• Operational Analysis & Improvement: Conduct in-depth technical analysis (using tools like PI and suite GEMBAs) and collaborate with leadership to implement quality and process improvements.
• Quality Systems Ownership: Own, drive, and support critical quality deliverables, including Deviations, CAPAs (Corrective and Preventive Actions), Change Controls, and OTNs, and lead/participate in Risk Assessments.
• Compliance & Documentation Review: Serve as the Manufacturing representative to assess and approve documentation, including Change Controls, Process Validation studies/reports, and various manufacturing documents.
• Customer & Cross-Functional Engagement: Lead collaboration with internal support departments and external customers to develop/update policies, identify/escalate risks, and communicate execution plans.
• Team Mentorship & Development: Provide direct mentorship, management, and oversight to junior specialists and project associates, supporting team development and growth toward strategic asset goals.

Minimum Required Qualifications

• Experience & Expertise: Requires an advanced background in a cGMP manufacturing environment with significant experience in Project Management and deep technical/quality knowledge.
• Project & Quality Systems Mastery: Proven ability to manage multiple complex projects simultaneously and expertise in key quality deliverables such as Deviations, CAPAs, and Change Controls.
• Technical & Documentation Proficiency: Demonstrated proficiency as a Subject Matter Expert (SME), including technical analysis and the review/approval of complex manufacturing and technical documentation.
• Communication & Leadership: Excellent written and verbal communication skills with a proven ability to engage with external customers, lead cross-functional teams, and provide mentorship.
• Education: Bachelor's degree in Engineering, Life Sciences, or related field.

E very 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.

Reference: R70719

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