Process Excellence Lead – GMP & Continuous Improvement

National Resilience; United States; On-site; USD 100,000 - 149,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Healthcare package

Paid vacation

Paid holidays

Tuition reimbursement

Family benefits

Caregiving support

Job summary

Resilience is seeking a Process Lead for the Process Execution Team to standardize practices and drive continuous improvement across lines, including LEAN and Six Sigma initiatives. This role serves as a Process SME for IDAP or Sterile Ops PET, advising on line setup, changeover, SAP transactions, and training.

The role requires leadership, coaching, and strong communication to drive performance, with 24/7 operation flexibility.

Qualifications

• Minimum GMP/regulatory production experience.
• Fast-paced, customer-oriented manufacturing environment experience.
• Experience coaching and influencing to drive performance.
• Strong questioning, listening, feedback, and self-awareness.
• Leadership capabilities supporting customer focus and decision-making under pressure.
• Working knowledge of Veeva Vault and data analysis tools (Excel, PowerBI).
• Shift flexibility to support 24/7 operations.

Responsibilities

• Develop standards/standard work for line setup and troubleshooting.
• Partner with technical teams on mistake-proofing and design improvements.
• Use KPIs, OEE, yields, and downtime data to drive improvements.
• Ensure compliance with regulatory standards and close gaps.
• Drive process confirmation and standardization across lines/shifts.
• Promote problem solving to address root causes on time.
• Spend ~20% of time on the floor.
• Lead regular Genba walks and coach operators.
• Manage deviation and change control records and track quality records to completion.
• Provide training in technical writing, Veeva navigation, and process flow.
• Lead bi-weekly staff meetings with the PET Lead.

Skills

GMP experience

Leadership

Coaching

Problem solving

Regulatory knowledge

LEAN manufacturing

Six Sigma

Communication

Veeva Vault

Excel

PowerBI

Decision making

Education

Bachelor’s degree in engineering or related science

Advanced technical degree or professional certification

Tools

Veeva Vault

Excel

PowerBI

Job description

Resilience is seeking a Process Lead for the Process Execution Team to standardize practices and drive continuous improvement across lines, including LEAN and Six Sigma initiatives. This role serves as a Process SME for IDAP or Sterile Ops PET, advising on line setup, changeover, SAP transactions, and training.

The role requires leadership, coaching, and strong communication to drive performance, with 24/7 operation flexibility.