Process Lead (Relocation Assistance)

Resilience•West Chester, OH

1d•$100,000 - $148,750•Onsite

About The Position

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. 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.

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.

Nice To Haves

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.

Responsibilities

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