Site Operational Excellence Lead

Secant Group; Quakertown (Bucks County); On-site; USD 80,000 - 100,000; Full time

Job summary

Secant Group in Quakertown, Bucks County, is seeking a Site Operational Excellence Lead. This role involves championing a culture of continuous improvement by identifying and executing performance improvement activities in line with strategic goals.

You will lead Continuous Improvement initiatives, train team members, analyze operational metrics, and ensure alignment with organizational objectives. Ideal candidates have a bachelor's degree in engineering and experience in the biopharmaceutical industry.

Qualifications

• Minimum bachelor’s degree in engineering or related discipline, or equivalent hands-on experience.
• Experience in medical or biopharmaceutical industry required.
• Proficient in MS Office and Excel.

Responsibilities

• Identify and prioritize business process improvements required to meet organizational goals.
• Lead Continuous Improvement culture across the site, providing training and mentorship.
• Analyze existing operational performance metrics and recommend improvements.

Skills

Performance improvement activities

Lean methodology

Analytical skills

Communication skills

Cross-functional teamwork

ISO 13485 and FDA guidelines

Six-Sigma training

Education

Bachelor's degree in engineering or related discipline

Tools

MS Office

eQMS

Job description

What We Are Looking For

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 provides recommendations for improvement opportunities.
• Develops and drives Site action plans pertaining to performance improvements and establishes Manufacturing Tier Meetings with Site leadership team members.
• Participates 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 biopharmaceutical industry required.
• Proficient computer skills using MS Office, Excel.
• 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.