QMS Process Engineer

Bachem Americas, Inc.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.

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

The company is listed on the SIX Swiss Exchange.

The Quality Management Systems (QMS) Process Engineer / Sr. Process Engineer plays a critical role within the Quality Systems and Compliance team. This position is responsible for supporting the ongoing development, maintenance, and oversight of a new electronic QMS, along with transitioning from the existing EQMS, and associated Quality system processes across Bachem's U.S. sites, while also partnering with QA and other stakeholders at European locations.

Additionally, the incumbent serves as a subject matter expert in electronic quality systems implementation, including but not limited to Veeva, Master Control, LIMS, and SAP.

This is a fulltime salaried position with full benefits. The role is primarily dedicated to supporting a quality system migration project with an anticipated duration of two years. It is expected the role will transition into the larger quality organization upon completion of project.

• Manage QMS system enhancement projects and collaborate locally and globally with the continuous improvement, maintenance, and oversight of the Quality Systems.
• Assist with improving metrics/calculations and issuing reports to assess the health of Bachem US quality system including Global level reporting and assessment.
• Process mapping, draft, and review of GMP documentation e.g. SOPs, protocols, reports.
• Proactively develop, identifying harmonization potential and optimization of global GMP concept and quality practices within the Bachem Quality Assurance organization within the US and across international sites.
• Suggest and implement improvements in quality systems, policies, and SOPs taking into account LEAN GMP approaches to optimize and improve existing processes in quality.
• Resolve problems with GMP electronic systems and provide guidance on EQMS topics, providing hands‑on support for local sites for the effective and lean implementation of these GMP processes and concepts.
• Collaborate with QA team members and with other departments to implement improved QMS processes, systems quality culture and documentation landscape.
• Support GMP audits for internal operations, GMP compliance improvements and provide GMP compliance guidance to other departments and BAM Sites as needed.

• Bachelor's Degree in scientific or technical discipline (chemistry, biotechnology, engineering, life sciences).
• Master's Degree (preferred).
• 5+ years' experience in Quality Assurance with a cGMP Manufacturing organization.
• 2+ years' project management experience (preferred).
• Excellent written and oral communication skills and experience in writing standard operating procedures (SOP), and process mapping.
• Experience with supporting/conducting audits and developing quality system metrics.
• Comprehensive knowledge of electronic software used in quality systems (e.g. Veeva Master Control, LIMS, SAP etc.).
• Ability to manage projects, organize and work in a fast‑paced environment.
• Ability to communicate in a proactive and solution‑focused manner, including keeping management aware of potential issues.
• Detail oriented with the ability to troubleshoot and resolve problems.
• Ability to work in a team environment and interact well with co‑workers, customers, regulatory agency auditors and senior management.
• Hands‑on experience with electronic system configuration (preferred).

Engineer: $82,969 - $114,083

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