Lonza · 1 day ago
Strategic Operations Project Specialist
Portsmouth, NH
Full-time
Onsite
Mid, Senior Level
5+ years expLonza is a global leader in life sciences, committed to manufacturing the medicines of tomorrow. The Strategic Operations Project Specialist will bridge the gap between technical expertise and project execution, driving site-wide goals in tech transfers, process improvements, and facility design changes.
BiotechnologyLife SciencePharmaceutical
Responsibilities
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
Qualification
Required
5+ years of experience in Biotechnology (Upstream and/or Downstream) or a similar manufacturing industry is required
High School Diploma or Equivalent is required
Proven experience owning technical projects from scope development to KPI reporting, with the ability to work independently and manage diverse stakeholders
Strong understanding of manufacturing equipment, Quality Control, and Quality Assurance, with the ability to perform technical analyses and flow path evaluations
Extensive experience with cGMP quality systems, change controls, and the review/approval of highly technical manufacturing and validation documentation
A proactive problem-solver who learns from experience, challenges the status quo to drive improvements, and aligns team objectives with corporate strategy
Preferred
A Bachelor's Degree in an industry-related discipline is preferred
Benefits
Medical, dental and vision insurance.
Company
Lonza
Lonza Group supplies products and services to pharmaceutical and agrochemical industries.
10001+ employees
H1B Sponsorship
Lonza has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2022 (1)
2021 (3)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$444.8M2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO
Leadership Team
Wolfgang Wienand
Chief Executive Officer
Alfons Ehinger
Founder
Recent News
NH Business Review
2026-01-17
Company data provided by crunchbase