Sr Manager, Site Operational Excellence

Fresenius Kabi USA, LLC; Warrendale (Allegheny County); On-site; USD 120,000 - 180,000; Full time

Job summary

Fresenius Kabi USA, LLC in Warrendale seeks a senior OpEx leader to define and execute the OpEx strategy for current and future budget years. You will guide the site team to identify, prioritize, and deliver improvements aligned with TechOps goals, ensuring regulatory compliance and cost efficiency.

Responsibilities include owning the Warrendale improvement road map, mentoring Lean Six Sigma practitioners, and coordinating cross‑functional efforts across Manufacturing, Quality, Operations and

Qualifications

• Must speak, read, write, and understand English.
• Ability to prioritize and work independently.
• 10 years of overall experience in improvement processes and complex projects.
• 5 years' experience in medical device, pharmaceutical, life science, or other manufacturing within a cGMP environment preferred.
• Lean Six Sigma Black Belt certification or equivalent experience required.
• 3 years' experience leading continuous improvement projects and delivering tangible results.
• Excellent analytical and technical skills.
• Excellent written and verbal communication skills.

Responsibilities

• Directs and supports OpEx improvement programs to drive regulatory compliance, cost and growth.
• Owns the Warrendale Improvement Road Map to achieve improved regulatory compliance and EBIT growth.
• Establishes and manages OpEx team and reports weekly achievements.
• Leads project teams to deliver against plant EBIT targets using Lean/Six Sigma methodologies.
• Coaches lean six sigma belts and provides project analysis support across the plant.
• Conducts annual belt training for new hires on OpEx concepts.
• Maintains plant scorecard and tracks critical metrics.
• Manages project spending against approved budgets.
• Supervises external continuous improvement consultants with site leadership.
• Provides cross‑functional leadership across Manufacturing, Quality, Operations, and Supply Chain.
• Implements Lean/Six Sigma methods and financial tracking of OpEx results.
• Develops training and best practices within the MedTech TechOps OpEx community.
• Reports outcomes to plant and regional management on a periodic basis.
• Ensures compliance with Health, Safety, Environment, and Quality requirements.

Skills

Lean Six Sigma

Project management

cGMP experience

English proficiency

Education

B.S. in Engineering/Life Sciences/Finance

Job description

Job Summary

The position leads, creates and executes the OpEx strategy & road map for the current budget year and future years. Supports the PU Warrendale leadership team to identify, prioritize and deliver OpEx improvements within timescales and budget. Responsible for developing and managing the delivery of Operations Excellence activities in accordance with the requirements identified in the annual Fresenius Kabi MedTech TechOps Goals and Objectives.

Please note: This position cannot provide employment-based immigration sponsorship now or in the future. Applicants must be currently authorized to work in the United States for any employer and must be able to maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time, including in the instance when your current work authorization expires.

Responsibilities

• Directs and supports activities related to identifying, prioritizing and implementing Site OpEx Improvement Programs, to drive improved Regulatory Compliance, Cost and Growth of MedTech Devices & Spare Parts.
• Owns the PU Warrendale Improvement Road Map to achieve improved regulatory compliance, efficiency improvements, and growth of the plant.
• Establishes and manages site OpEx Team direct report personnel to complete continuous improvement projects and report on weekly achievements.
• Leads and directs project teams to deliver against plant EBIT targets utilizing appropriate methodologies.
• Coaches lean six sigma belts and provides technical support as required on a plant-wide basis for project analysis in terms of operational efficiency.
• Conduct annual belt training for new hires to ensure all employees have a basic understanding of OpEx lexicon and lean waste reduction.
• Maintains the plant scorecard of critical metrics in performance where applicable.
• Manages accounting for project spending against agreed to project budgets.
• Supervises and coordinates efforts of external continuous improvement consultants in conjunction with the site leadership team.
• Provides leadership amongst site peers and the leaders of Manufacturing, Quality, Operations, Supply Chain and other critical functions within the plant to drive local changes.
• Supports organizational development and teambuilding activities.
• Manages the OpEx project resources necessary to deliver the results with local site leadership.
• Ensures that OpEx projects are analyzed and delivered using the appropriate Lean/Six Sigma methodologies within the Site (such as DMAIC, Process Controls, Statistical Analyses).
• Defines and implements financial tracking of OpEx results within the site.
• Develops training and implementation of Lean/Six Sigma methodology, including sharing best practices within the MedTech TechOps OpEx community.
• Responsible for achieving goals, recording, and reporting key outputs to plant and regional management on a periodic basis.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

REQUIREMENTS

• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
• Ability to prioritize and work independently with little to no supervision.
• B.S. degree in Engineering, Life Sciences, or Finance related field required.
• 10 years of overall experience, managing improvement processes and complex projects.
• 5 years' experience of medical device, pharmaceutical, life science, or other manufacturing within a cGMP environment preferred.
• 3 years' experience in electro-mechanical operations preferred.
• Lean Six Sigma Black Belt certification or equivalent experience required.
• 3 years' experience successfully leading continuous improvement projects and delivering tangible results required.
• Excellent analytical and technical skills.
• Excellent written and verbal communication skills.Must be able to communicate and can interact with all levels of the organization and manage in a dynamic environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.