QMS Process Engineer in Vista, California at 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 Americas, Inc.

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. For further information, see www.bachem.com.

A brief overview

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, MasterControl, LIMS, and SAP.

Expected duration: 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.

What you will do

• 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.

Qualifications

• Bachelor's Degree in scientific or technical discipline (chemistry, biotechnology, engineering, life sciences)
• Master's Degree 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 MasterControl, 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)

Base Annual Salary Ranges:

Engineer: $82,969 - $114,083

Sr. Engineer: $103,104 - $141,768

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

 Corporate Social Responsibility

 Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness.EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.