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Cambrex

Global CDMO for drug substances

Operational Excellence Principal Engineer

Bioprocess & BiomanufacturingPosted on Nov 10
Full-timeCharles City, IA, USANo salary listedIn-person

About the Job

Requirements

  • Advanced knowledge of Lean Manufacturing, Six Sigma, and operational excellence systems.
  • Strong chemical engineering fundamentals and the ability to apply them in a manufacturing environment.
  • Demonstrated ability to lead large, cross-functional improvement initiatives with measurable results.
  • Understanding of process capability, variation reduction, bottleneck management, and waste elimination.
  • Strong project leadership, facilitation, coaching, and change-management skills.
  • Financial acumen and the ability to quantify, communicate, and validate business impact.
  • Excellent written, verbal, and presentation skills.
  • Bachelor's degree in Chemical Engineering from an accredited institution.
  • Lean Six Sigma Green Belt certification at minimum; a higher belt is preferred.
  • Seven or more years of progressive experience in manufacturing, process engineering, operational excellence, or continuous improvement.
  • Demonstrated experience leading significant cross-functional projects that delivered measurable improvements in operational or financial performance.

Responsibilities

  • Inspire and drive a site culture focused on safety for all employees.
  • Develop improvements that release incremental capacity from existing assets, systems, workflows, and labor resources.
  • Collaborate with cross-functional teams to improve process robustness, equipment utilization, reliability, and manufacturing efficiency.
  • Apply statistical analysis, root-cause analysis, Failure Mode and Effects Analysis, process capability analysis, regression, and Design of Experiments to complex operational problems.
  • Analyze process flow, chemistry, variability, constraints, and resource utilization to improve manufacturing predictability and performance.
  • Lead Define, Measure, Analyze, Improve, Control; Plan, Do, Check, Act; Kaizen; and other structured problem-solving efforts.
  • Evaluate automation, digital, and emerging technology opportunities that simplify work and improve operational visibility or control.
  • Support process transfers, scale-up, capital projects, technology implementation, and operational readiness activities.
  • Establish baselines, define success measures, and validate realized savings and operational benefits with process owners and Finance.
  • Support sustainment of Lean Manufacturing, Total Quality Management Daily Management, leadership standard work, visual management, tiered accountability, 6S, and structured problem-solving systems.
  • Mentor Lean Six Sigma practitioners and cross-functional project teams to strengthen site capability.

Desired Qualifications

  • A higher Lean Six Sigma belt than Green Belt.

About the Company

Cambrex

Global CDMO for drug substances

Cambrex is a global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, plus analytical and IND enabling services. It uses a range of specialized technologies—such as continuous flow chemistry, handling of controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and production of highly potent APIs—to develop and manufacture drug substances for clients. The company differentiates itself with over 40 years of experience, a staff of about 2,000 experts, and a global footprint in North America and Europe, offering end-to-end capabilities from early development through commercial-scale manufacturing. Its goal is to help clients bring new medicines to market by delivering integrated, reliable drug substance development and manufacturing and related analytical support.

Company size
1,001-5,000
Company stage
IPO
Headquarters
East Rutherford, NJ
Founded
1981

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