Site Operational Excellence Lead

Solesis; Quakertown (Bucks County); On-site; USD 115,000 - 165,000; Full time

Job summary

Solesis is seeking a Site Operational Excellence Lead in Bucks County to drive continuous improvement across the site and align with global objectives. You will champion Lean practices, mentor teams, and work with site leadership to enhance capabilities, reduce costs, and improve customer service metrics.

The role requires strong analytical and communication skills, experience in medical/pharma environments, and familiarity with ISO 13485 and FDA guidelines.

Qualifications

• Bachelor’s degree in engineering required.
• Experience in medical or bio pharmaceutical industry required.
• Strong analytical, organizational and communication skills.
• ISO 13485 and FDA guidelines experience preferred.
• Six-sigma training (Green Belt/Black Belt) a plus.

Responsibilities

• Identify and prioritize improvements to achieve site goals (AOs and BTOs).
• Lead a culture of Continuous Improvement and mentor teammates.
• Implement Site CI program with Lean, 5S, VSM/PFMs, RCA and other CI tools.
• Analyze run-rates, waste, capacity, and yields; recommend improvements.
• Develop and drive site action plans and Manufacturing Tier Meetings.
• Participate in global OE and network meetings for standardization.
• Coordinate with stakeholders for resourcing and prioritization.
• Establish Site KPIs with leadership to track performance.
• Identify opportunities for cost savings and prioritize resource allocation.
• Lead CI events like Kaizens, Tiger Teams, CI Projects.
• Conduct operational reviews and audits.
• Identify staffing requirements and participate in hiring.

Skills

Analytical skills

Organizational skills

Communication skills

Education

Bachelor’s degree in engineering

Six-sigma training (Green Belt/Black Belt)

Experience with ISO 13485 and FDA guidelines

Tools

ERP system

eQMS

Job description

The Site Operational Excellence Lead identifies, plans, and executes performance improvement activities across the facility and in alignment with organizational strategic goals and objectives. Through the implementation of lean methodology and other best practices, you will champion a culture of continuous improvement by empowering others to seek better ways of working. This role will work closely with Site leadership team members to enhance production capabilities, improve quality,reduce costs, and achieve customer service goals.

What you will do:

• Identifies and prioritizes business process improvements and critical initiatives required to achieve both short-term and longer-term organizational goals - Annual Objectives (AOs) and Break Through Objectives (BTOs).
• Leads and supports a culture of Continuous Improvement across the site and provide training and mentorship as needed in support of Operational Excellence initiatives.
• Provides and implements a Site Continuous Improvement program in coordination with global organizational support, inclusive of training and execution around Lean, 5S, VSM/PFMs, Root Cause Analysis, and other “best practices” CI tools and methodologies.
• Analyzes existing operational performance metrics such as run-rates, waste, capacity, and yields and provide recommendations for improvement opportunities.
• Develops and drives Site action plans pertaining to performance improvements and establishes Manufacturing Tier Meetings with Site leadership team members.
• Participate in global Operational Excellence and network team meetings to collaborate and ensure standardization of best practices and alignment on organizational activities.
• Meets with key stakeholders as required to ensure proper resourcing alignment, prioritization, constraints identification, etc. on departmental activities.
• Establishes Site Key Performance Indicators (KPIs) with local leadership to ensure performance targets are communicated and transparent throughout the facility.
• Identifies top opportunities for Cost Savings and helps prioritize best allocation of resources to execute and realize these savings for leadership review.
• Leads Continuous Improvement events such as Kaizens, Tiger Teams, and/or CI Projects as necessary to elevate business productivity and provide team members with structured support and tools to resolve issues/opportunities.
• Conducts operational reviews and audits.
• Identifies staffing requirements, participates in selection and hiring process, interviews applicants, and makes hire recommendations.

Who you are:

• Minimum bachelor’s degree in engineering or a related discipline, or equivalent combination of education and hands‑on experience.
• Experience with medical or bio pharmaceutical industry required.
• Strong analytical, organizational and communication skills.
• Both independent self-starting work habits and as a cross-functional team member.
• Results Oriented: Being persistent and showing perseverance in achieving concrete and tangible results out of personal responsibility; getting optimum results from situations and being ready to act and show drive in case of obstacles or resistance.
• Experience with ISO 13485 and FDA guidelines.
• Six-sigma training a plus (Green Belt and/or Black Belt)
• Ability to effectively communicate with coworkers and management. Business communication is conducted in English.
• Familiarity with an ERP system and Quality Management System (eQMS) preferred.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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