Sr. Process Improvement Specialist

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

Job summary

Bachem Americas is seeking a Sr. Process Improvement Specialist to analyze manufacturing data, identify improvements, and apply statistical methods to boost efficiency and robustness across production lines.

You will generate KPIs, lead data acquisition, coordinate multiple projects, and ensure compliance with the Bachem Quality Management System and cGMP, with SAP involvement and cross-site collaboration. This role requires a life sciences or related degree and 4+ years in process improvement,

Qualifications

• Bachelor's degree in life sciences, computer information systems or related field.
• 4+ years with reporting tools such as Hyperion/Brio or other statistical software
• 4+ years of process improvement or operations experience
• SAP experience (preferred)
• Pharma manufacturing exposure and cGMP experience preferred
• Strong communication, organizational and problem-solving skills
• Experience with statistical analysis in pharma manufacturing (preferred)
• Familiarity with SAP transactions and troubleshooting

Responsibilities

• Analyze manufacturing processes and apply techniques to improve efficiency.
• Generate KPIs and report process performance to leadership.
• Lead data acquisition processes and manage multiple time-sensitive projects.
• Identify variability causes and apply process maps and quality metrics.
• Define quality metrics and monitor continuous process verification.
• Draft MBPRs, SOPs, deviations, investigations and CAPAs tracking.
• Ensure compliance with Bachem QMS and cGMP guidelines.
• Assist managers with data entry and coordinating production activities.

Skills

Excellent verbal communication

Written communication

Presentation skills

Organizational skills

Time management

Analytical thinking

Problem-solving

Cross-functional collaboration

Statistical analysis

Power BI

Minitab

Adonis

Education

Bachelor's degree in life sciences or related field

Tools

SAP

Hyperion/Brio

Power BI

Minitab

Adonis

Job description

A Brief Overview

The Sr. Process Improvement 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

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.