QMS Process Engineer

Responsibilities

• Manage QMS system enhancement projects and collaborate globally on the continuous improvement and oversight of Quality Systems.
• Assist with improving metrics and issuing reports to assess the health of the U.S. and global quality systems.
• Perform process mapping and draft/review GMP documentation, including SOPs, protocols, and reports.
• Identify harmonization potential and optimize global GMP concepts and quality practices across international sites.
• Implement improvements in quality systems and policies using LEAN GMP approaches.
• Resolve problems with GMP electronic systems and provide hands-on support for effective implementation of processes.
• Support GMP audits for internal operations and provide compliance guidance to various departments.

Requirements

• Bachelor's Degree in a scientific or technical discipline (e.g., chemistry, biotechnology, engineering, or life sciences).
• 5+ years of experience in Quality Assurance within a cGMP manufacturing organization.
• Strong experience in writing standard operating procedures (SOPs) and process mapping.
• Experience supporting or conducting audits and developing quality system metrics.
• Comprehensive knowledge of electronic software used in quality systems, such as Veeva, MasterControl, LIMS, or SAP.
• Excellent written and oral communication skills with the ability to work in a fast-paced, team-oriented environment.

Preferred Qualifications

• Master's Degree in a relevant scientific or technical field.
• 2+ years of project management experience.
• Hands-on experience with electronic system configuration.

Benefits

• Competitive base annual salary.
• Annual performance bonus.
• Comprehensive Medical, Dental, and Vision coverage.
• 401(k) plan with employer contribution.
• Paid vacation, personal, and sick days.

About the Company

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of expertise, Bachem provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide. The company operates internationally with headquarters in Switzerland and locations across Europe, the US, and Asia.