Engineer II, Early Phase Clinical Manufacturing

United States, Bend (Oregon)

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.

Lonza Pharma & Biotech has an excellent opportunity for an experienced Engineer to support Early Phase Clinical Manufacturing within the Product Development team at Lonza’s Bend, Oregon location.

Key Responsibilities:

  • Contribute to culture of safety during all tasks, including development and application of safety procedures
  • Utilize technical expertise to consistently produce high quality deliverables and clinical trial supplies
  • Lead technology transfer, risk mitigation, and batch execution in early phase clinical GMP pilot plant
  • Routinely apply working knowledge of the product lifecycle, including relevant regulatory guidance (e.g. ICH)
  • Represent EPCM as technical SME in collaborative partnerships with customers and internal project teams
  • Support equipment design and CQV activities as technical SME and end system user
  • Utilize math, chemistry, and engineering fundamentals for pharmaceutical product and process development
  • Independently solve problems, formulate recommendations, and make decisions; escalate challenges as appropriate
  • Critically review and interpret data in order to support decisions that advance product development programs
  • Apply ownership mentality to process equipment and manufacturing space; ensure high performance and compliance with safety and/or regulatory requirements
  • Prepare clear written documents such as SOPs, tech transfer materials, batch records, protocols, reports, memos, and training materials
  • Identify and own continuous improvements in techniques and processes (business and/or manufacturing)
  • Complete tasks with attention to detail and consistent with GDP requirements
  • Support technical investigations in root cause analysis, product impact assessment, and effective CAPA definition
  • Track and regularly communicate/coordinate tasks across multiple projects and timelines
  • Act as a technical and professional mentor for junior colleagues
  • Routinely: strive for excellence, practice critical thinking, show compassion, and laugh
  • Perform other duties as assigned

Key Requirements:

  • Requires a university degree in chemical engineering or related engineering/scientific field
  • Advanced experience in chemical engineering, drug development or related field, including relevant graduate school experience 
  • Significant work experience in the pharmaceutical industry
  • Strong leadership, writing, and communication/presentation skills are required
  • Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making

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.

Reference: R42314