Process Lead (Relocation Assistance)

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

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Brief Job Description

Accountable for driving standardization of practices and continuous improvement across the Process Execution Team (PET). This individual will serve as a Process SME for the IDAP or Sterile Ops PET, advising, and leading by example in areas including tier communication processes, efficient

operation, line clearance, changeover, SAP transactions, training, deviation and change control

management, and other areas as needed. Additionally, through a focus on LEAN and Problem

Solving the Process Lead will help the PET Lead drive performance improvements.

Job Responsibilitie s

• * Works with teams to develop standards/standard work for line set-up, center lining,

troubleshooting, etc.

• * Partner with area technical team on mistake-proofing/design improvements for the lines and

processes

• * Leverages performance data (e.g., KPIs, OEE, Yields, Downtime) to drive improvement across all shifts/lines.
• * Understanding regulatory and company global standards and potential gaps, then driving

implementation to close gaps

• * Process confirmation and drive a common approach across all lines/shifts.
• * Drive an increased focus on problem solving - both in timeliness and quality (we will not stop until we have identified and addressed the root cause)
• * Spend 20% of time on the floor.
• * Actively driving continuous improvement and standardization
• * Involved in regular Genba walks ensuring actions are recorded for process improvement and

coaching is provided to area operators.

• * Manages deviation and change control records as needed and tracks progress of quality records to completion.
• * Provides training to colleagues in technical writing, Veeva navigation and process flow.
• * Leads bi-weekly Staff meetings in collaboration with the PET Lead

Education, Qualifications, Skills, and Experience

Minimum Requirements

• * Considerable experience in GMP or regulated production environment
• * Experience in a manufacturing or operations-based field/industry involving a fast-paced,

customer-oriented environment.

• * Experience coaching and influencing others to drive performance.
• * Experienced in demonstrating skills in the areas of asking questions, listening, providing

feedback, self-awareness.

• * Display of Leadership capabilities that support customer focus, integration of diverse views, ability to make decisions under pressure, and develop an objective view of others' capability to provide

coaching and feedback in the moment and continually develop his/herself.

• * 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
• * Ability to coach and mentor peers.

Preferred Background

• * Bachelor's degree in engineering or a related science
• * Advanced technical degree or professional certification
• * Pharmaceutical Industry experience
• * Knowledgeable in change management
• * Uses their insight to challenge and adapt current approaches/ways of doing things.
• * Experience in Six Sigma/analytical troubleshooting skills
• * Experience working in a LEAN manufacturing environment.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

Our target base pay hiring range for this position is $100,000.00 - $148,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge.