Senior Viral Vector Process Engineer - Drive Manufacturing

Lonza Biologics, Inc.; Houston (TX); On-site; Confidential; Full time

Benefits offered by this job

Relocation assistance

Benefits vary by role/location

Job summary

Lonza Biologics, Inc. in Houston, TX seeks a Senior Process Engineer – Viral Vector to lead manufacturing support, troubleshoot equipment and processes, and drive continuous improvement.

The role collaborates with reliability engineers and production to identify new equipment and enhance performance. The successful candidate will apply GEP/cGMP knowledge, develop URSs and SOPs, and own change controls and validation activities while working with cross-functional teams to deliver high-quality

Qualifications

• Bachelor degree in Chemical, Mechanical, Industrial, Electrical or related fields.
• 5-10 years of experience in Pharmaceutical or Biotechnology Manufacturing.
• Strong troubleshooting, analytical, and problem-solving skills with ability to improve processes, equipment performance, and automation functionality.
• Ability to develop URSs, technical specifications, standards, drawings, SOPs, and documentation while supporting validation, audits, and continuous improvement efforts.
• Must have a deep understanding of GEP/cGMP/GDP and how they relate to maintenance and documentation.
• Must be able to work with minimum supervision.
• Must have excellent leadership skills.
• Able to record information accurately and write official documents.
• Able to perform procedures according to written guidelines and recognize a deviation from accepted practice.
• Able to use spreadsheets, databases and word processing software.
• Able to effectively communicate with peers and supervisors verbally and in writing.
• Able to multi-task and display effective time management in managing projects.
• Self-motivated, works well independently and as a team player.
• Must have a deep understanding of RCM and Total Productive Maintenance (TPM).
• Understanding of process improvement and reliability engineering principles, methodologies and tools

Responsibilities

• Lead the support to manufacturing by troubleshooting equipment and process issues.
• Collaborate with Reliability engineer to improve equipment reliability and support maintenance programs.
• Provide engineering support to production in identifying new equipment suited to process requirements.
• Monitor processes and lead the implementation of continuous improvement initiatives.
• Lead failure analysis exercises and support corrective action implementation.
• Own and drive change controls, deviations, and validation activities.
• Work with cross-functional teams to improve performance.
• Develop URSs, technical specifications, standards, drawings, SOPs, and documentation while supporting validation, audits, and continuous improvement efforts.

Skills

Troubleshooting

Process improvement

Leadership

Documentation

Reliability engineering

GMP knowledge

Cross-functional collaboration

URS writing

Education

Bachelor's degree in Chemical/Mechanical/Industrial/Electrical or related fields

Job description

Lonza Biologics, Inc. in Houston, TX seeks a Senior Process Engineer – Viral Vector to lead manufacturing support, troubleshoot equipment and processes, and drive continuous improvement.

The role collaborates with reliability engineers and production to identify new equipment and enhance performance. The successful candidate will apply GEP/cGMP knowledge, develop URSs and SOPs, and own change controls and validation activities while working with cross-functional teams to deliver high-quality