Process Excellence Lead

Resilience; Port Union (OH); On-site; USD 100,000 - 149,000; Full time

Benefits offered by this job

401(k) plan with company match

Healthcare (medical, dental and vision

Paid vacation and holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience is a tech-focused biomanufacturing company transforming how medicine is made, based in the United States. This role drives standardization across the Process Execution Team, serving as a Process SME for IDAP or Sterile Ops PET, advising on change control, training, and LEAN improvements to elevate performance across lines.

Responsibilities include developing standard work, improving line efficiency, and coaching operators while maintaining regulatory alignment.

Qualifications

• Considerable experience in GMP or regulated production environment.
• Experience in a manufacturing or operations-based field with a fast-paced, customer-oriented environment.
• Experience coaching and influencing others to drive performance.
• Skills in asking questions, listening, providing feedback, self-awareness.
• Leadership capabilities that support customer focus and decision making under pressure; develop others.
• Working knowledge of Veeva Vault and data analysis tools such as Excel and PowerBI.
• Flexibility to adjust shift schedule to support 24/7 operations.
• Ability to direct self and others in a project environment; coach and mentor peers.

Responsibilities

• Develop standards/standard work for line setup and center lining.
• Partner with area technical team on mistake-proofing and design improvements for lines and processes.
• Leverage KPIs (OEE, yields, downtime) to drive improvement across shifts/lines.
• Understand regulatory and global standards and close gaps with implementation.
• Process confirmation and drive a common approach across lines/shifts.
• Focus on timely, high-quality problem solving and root-cause analysis.
• Spend 20% of time on the floor; conduct Genba walks and record actions.
• Drive continuous improvement and standardization; coaching for operators.

Skills

Leadership

GMP knowledge

Lean manufacturing

Six Sigma

Problem solving

Data analysis

Communication

Coaching

Regulatory awareness

Veeva Vault knowledge

Education

Bachelor's degree in engineering or related science

Advanced technical degree or professional certification

Pharmaceutical Industry experience

Change management knowledge

LEAN manufacturing environment experience

Six Sigma / analytical troubleshooting skills

Tools

Veeva Vault

Excel

Power BI

Job description

Resilience is a tech-focused biomanufacturing company transforming how medicine is made, based in the United States. This role drives standardization across the Process Execution Team, serving as a Process SME for IDAP or Sterile Ops PET, advising on change control, training, and LEAN improvements to elevate performance across lines.

Responsibilities include developing standard work, improving line efficiency, and coaching operators while maintaining regulatory alignment.