Senior Specialist II, Business Operations

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

Position Summary & Responsibilities: This position champions and leads operational excellence and lean activities to systematically eliminate waste, non-value-added activity, and reduce process variation. Additionally, the specialist manages site metrics and dashboard program to drive data-based decisions for project selection and projectresourcing.

• Lead and coordinate investigations and studies with little supervision
• Lead process improvement activities and teams to meet strategic goals.
• Facilitate communication between management and non-management.
• Facilitate team meetings to discuss progress, initiatives, and/or other matters.
• Provide leadership, development, and mentoring for others.
• Supervise day to day activities of others
• Develop lean processes and procedures
• Identify temporary and permanent fixes to address issues
• Attend inter-departmental meetings to discuss matters involving the coordination of multipledepartments
• Facilitate inter-departmental meetings to discuss matters involving the coordination of multiple departments
• Coordinate with representatives from other departments
• Interact with other departments to implement corrective/preventative actions
• Participate in cross-functional teams to meet strategic goals
• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required byspecific activities
• Monitor and analyze process equipment performance
• Assess and implement improvements in productivity, waste generation, quality, and cost
• Assign work tasks and activities to others
• Lead committees or groups of employees tasked with accomplishing some objective(s)
• Create new process modifications
• Represent the site in organization-wide projects and meetings
• Prepare documentation of activities, actions, and/or results
• Read SOPs (Standard Operating Procedures) and excerpts from technical documentation
• Conduct troubleshooting activities
• Train others on systems, software, equipment, machines, procedures, and/or processes
• Establish visual tracking and other tools to enhance audit readiness and trend analysis
• Fill in for immediate supervisor when absent
• Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions
• Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements
• Monitor key performance indicators to meet strategic goals
• Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions forcGMP
• Monitor equipment and/or systems for performance and problem indicators

Minimum Qualifications

• Extensive experience leading lean initiatives within a regulated or cGMP environment
• Strong project management experience
• Must have the ability to effectively understand, read, write, communicate and follow instructions
• Working knowledge of Microsoft Excel, Word and PowerPoint
• Good organizational and analytical skills
• Good attention to detail.
• Capable of keeping accurate records and performing mathematical calculations.
• Demonstrated ability to design, lead, facilitate, and actively participate in meetings with cross-functional teams

Preferred Qualifications

• Bachelor's degree in engineering or a technical discipline
• IASSC Certified Lean Six Sigma Black Belt
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures

This position may also include the following conditions:
Physical and Mental Requirements Frequent
Lifting/Carrying 40 lbs. X
Working at Heights of 5 ft.
Sitting X
Standing X
Walking X
Bending X
Stooping X
Twisting X
Reaching X
Repetitive Motion X
Noise Exposure X
Operating Vehicles
Operative Moving Machinery
Chemical Usage X
Traveling X
Speaking Publicly
Monitoring Other People's Work
Wearing Personal Protective Equipment X

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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.