Strategic Operations Project Specialist

Strategic Operations Project Specialist

Location: Portsmouth, NH, USA

Step into a high-impact, intermediate-level role where you will bridge the gap between technical expertise and project execution, driving site-wide goals in tech transfers, process improvements, and facility design changes.

See what a role at Lonza (Portsmouth, NH) looks like—watch this short video!

What you will get

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

• Medical, dental and vision insurance.

Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do

• Serve as the primary technical representative for manufacturing processes on cross-functional teams, collaborating with MSAT, QA, Engineering, and Validation to achieve departmental and site-wide goals.

• Lead medium-to-large scope projects from concept to completion, including tech transfers, interdepartmental readiness, and facility design changes.

• Act as a Subject Matter Expert (SME) for process equipment design and operation, providing technical analysis using PI data, batch record reviews, and suite GEMBAs.

• Own and drive key Quality initiatives, including the execution of Out of Tolerance (OTN) events, particulate investigations, CAPA actions, and Lab Investigation Reports (LIRs).

• Manage the full lifecycle of change requests and technical documentation, including the review and approval of Batch Records, SOPs, and Functional Design Specifications (FDS).

• Oversee the procurement and integration of small equipment, ensuring systems meet technical specifications, budget requirements, and data integrity standards.

• Support Strategic Operations Associates through training, project planning, and issue resolution, while representing Lonza in Joint Project Teams (JPT) and customer interactions.

What we are looking for

• Experience: 5+ years of experience in Biotechnology (Upstream and/or Downstream) or a similar manufacturing industry is required.

• Education: High School Diploma or Equivalent is required; a Bachelor’s Degree in an industry-related discipline is preferred.

• Project Mastery: Proven experience owning technical projects from scope development to KPI reporting, with the ability to work independently and manage diverse stakeholders.

• Technical Knowledge: Strong understanding of manufacturing equipment, Quality Control, and Quality Assurance, with the ability to perform technical analyses and flow path evaluations.

• Quality & Compliance: Extensive experience with cGMP quality systems, change controls, and the review/approval of highly technical manufacturing and validation documentation.

• Agility & Business Acumen: A proactive problem-solver who learns from experience, challenges the status quo to drive improvements, and aligns team objectives with corporate strategy.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.