Sr. Process Improvement Specialist

Bachem Holding AG; Vista (CA); On-site; USD 94,000 - 129,000; Full time

Benefits offered by this job

Competitive pay

Annual bonus

Medical/Dental/Vision coverage

401(k) with employer contributions

Paid vacation & sick days

Job summary

Bachem Americas seeks a Sr. Process Improvement Specialist to collect, analyze, and visualize production data, driving enhancements in efficiency and robustness across manufacturing.

The role interfaces with multiple functional areas and may involve SAP for Production activities, influencing strategies and portfolio assessment. The position emphasizes data-driven decision making, KPI development, and cross-functional collaboration within a cGMP environment.

Qualifications

• Bachelor's degree in life sciences, computer information systems or related field.
• 4+ years of experience with reporting tools such as Hyperion/Brio or other statistical software systems.
• 4+ years of process improvement or operations experience.
• SAP experience (preferred).
• Pharmaceutical manufacturing experience and working in a cGMP environment (preferred).
• Experience with statistical analysis applied to pharmaceutical manufacturing (preferred).
• Knowledge of SAP transactions and troubleshooting.
• Excellent verbal, written communication and presentation skills.
• Strong cross-functional collaboration and problem-solving abilities.

Responsibilities

• Analyze manufacturing processes and apply analytical techniques to identify improvements.
• Generate KPIs to guide strategic and operational manufacturing improvements.
• Lead data acquisition standardization across projects and manage multiple time-sensitive efforts.
• Assess impact of process parameters using process maps and quality metrics for customers.
• Define quality metrics and monitor Continuous Process Verification; present findings to stakeholders.
• Draft and review MBPRs, SOPs, deviations, investigations, and CAPAs to meet timelines.
• Ensure compliance with Bachem QMS and cGMP guidelines.
• Assist managers with planning systems data entry and coordinating production activities.

Skills

Statistical analysis

Data visualization

Power BI

Minitab

SAP

Communication

Cross-functional

Problem solving

Education

Bachelor's degree in life sciences or related field

Tools

Hyperion Brio

Minitab

Power BI

Job description

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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

TheSr. ProcessImprovement Specialist is responsible for the collection, statistical analysis and visualization of production data to support the manufacturing team in increasing process performance, robustness and efficiency. The Specialist will identify and apply appropriate analytical techniques to gather data, identify areas of improvement and recommend necessary process controls or other actions to increase process efficiency. The specialist will be an individual contributor while reporting to the production department and coordinating with other involved functional areas as well as other sites if necessary. The Specialist may work as the key user of SAP for Production and Production related activities. The Specialist will have a significant impact on manufacturing strategies and in the assessment of the product portfolio.

What you will do

• Analyzing selected manufacturing processes, identifying and applying appropriate analytical techniques to gather data, identify areas of improvement, and recommending necessary process controls or other actions to increase process efficiency


• Generate Key Performance Indicators to provide a focus for strategic and operational improvements Report to department leadership on process performance of ongoing manufacturing projects.


• Lead efforts to develop standard data acquisition processes that can be applied to all projects, managing multiple time sensitive projects to deliver targeted outcomes, involvement in planning long-term or short-term business objectives and organizing departmental efforts to identify, prioritize, and assessing the impact of process parameters of ongoing manufacturing and training other team members to perform data analysis


• Organizing departmental efforts to identify, prioritize and assess the impact of process parameters of ongoing manufacturing, identifying causes of variability in multi-stage production processes utilizing process maps to illustrate manufacturing processes flow and defining quality metrics to illustrate the impact of process improvement to customers


• Define quality metrics to illustrate the impact of process improvement to customers, utilizing trend analysis to identify opportunities for improvement in manufacturing processes. Manage and monitor Continuous Process Verification programs. Present findings to stakeholders using PowerPoint, graphs, charts, etc.


• Draft and review MBPRs, SOPs, deviations, investigations, and other technical documents, tracking CAPAs related to the manufacturing department to ensure that commitments are met within established timelines


• Ensure compliance with the Bachem Quality Management system and with cGMP guidelines.


• Assist managers schedule, enter data using planning systems and coordinate production activities.

Qualifications

• Bachelor's degree in life sciences, computer information systems or related field


• 4+ years of experience with reporting tools such as Hyperion/Brio or other statistical software systems


• 4+ years of process improvement or operations experience


• SAP experience (preferred)


• Previous manufacturing experience, preferably in the pharmaceutical industry


• Experience working in a cGMP environment (preferred)


• Experience with statistical analysis applied to pharmaceutical manufacturing (preferred)


• Knowledge of SAP transactions and troubleshooting


• Excellent verbal, written communication and presentation skills.


• Excellent organizational skills


• Detail oriented with the ability to troubleshoot and resolve technical and analytical problems.


• Strong understanding of interdependencies with cross-functional stakeholders and business implications of decisions


• Positive and determined attitude with the ability to communicate in a proactive and solution-focused manner; keep management informed of potential issues


• Ability to work independently and manage one’s time


• Exposure to statistical reporting tools including Minitab, Adonis and Power BI

Base Salary Range:

$94,104 - $129,393

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

Total Rewards

• competitive pay


• annual performance bonus


• a generous benefit package with comprehensive Medical/Dental/Vision coverage


• 401(k) plan with employer contribution


• 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.

At Bachem, you’ll find a diverse, multicultural team. The (a)in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.