Senior Process Specialist, Blue Ash IDAP

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 Description

The Senior Process Specialist works directly with the Process Lead to driving standardization of processes, procedures, standard practices, and continuous improvement across the Process

Execution Team (PET). The Process Specialist performs tasks in support of the pharmaceutical manufacturing processes and helps the Process Lead drive performance improvements. The

position provides oversight, execution, and approval for transactions in SAP, MES and EDMS/QMS system.

Note: This role will be at new Blue Ash commercial manufacturing site and focus on Inspection, Device Assembly and Secondary Packaging (IDAP).

Position Responsibilities

• Works with teams to develop standards/standard work for line set-up, center lining, troubleshooting, etc.
• Strong performance history of consistently meeting or exceeding expectations.
• Ability to work independently with minimal guidance from management.
• Maintain an advanced knowledge of the SAP system. Train others on proper use of the ERP system and execute transactions as required.
• Guide team on SOPs (Standard Operating Procedures), work instructions, and MBRs (Master Batch Records).
• Instruct/Coach the PET members:
  • Process confirmation and drive a common approach across all lines/shifts.
  • Partnering with Process Supervisors to build skills matrix and close the gaps.
  • Lean and Problem-Solving tools / techniques / behaviors.
  • Drive an increased focus on problem solving - both in timeliness (stop line NOW and Root Cause Analysis) and quality (we will not stop until we have identified and addressed the root cause).

• Regularly spend time on the floor.
• Actively supporting continuous improvement and standardization across operational areas in the PET.
• Involved in regular Gemba walks ensuring actions are recorded for process improvement and coaching is provided to area operators.
• Establishing a clear vision, clear accountabilities, and helping to remove obstacles. Enabling Supervisor, Leads and Technicians to be more effective at their roles.
• Collaborate with cross functional teams.
• Seek and leverage the skills and technical expertise of internal and external resources to improve the speed and rigor of task completion.
• Maintain a high level of understanding of relevant production processes.
• Understand, evaluate, create, and revise processes and procedures for PET operations.
• Understand global standards and potential gaps, then driving implementation to those gaps.
• Use of Lean tools such as Level 0, HPEL, and Practice Problem Solving (PPS) to drive a culture that prevents unplanned deviations.
• Prioritizes work to aid in timely decisions and completion of tasks. Escalates issues as appropriate.
• Complete other duties as assigned by the Process Lead or PET Lead.

Minimum Qualifications

• Knowledge/experience of Inspection, Device Assembly, and Packaging processes/procedures.
• Experience in cGMP manufacturing environment.
• Ability to direct and participate in cross-functional team.
• Strong leadership, relationship management skills.
• Experience coaching and influencing others to drive performance.
• Experienced in demonstrating skills in the areas of asking questions, listening, providing feedback, and self-awareness.
• Ability and willingness to learn and adapt skills for various areas.
• Strong interpersonal skills with the ability to lead cross-functional teams.
• Flexibility to adjust shift schedule to support 24/7 operations.
• Ability to take accountability with excellent follow up and follow through.
• Excellent written and verbal communication skills, including technical writing for documents and reports.
• Must have proficient computer skills and be experienced in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
• Ability to work in a fast-paced team environment and adapt to changing business needs.

Preferred Qualifications

• High school graduate, vocational school graduate or equivalent
• Pharmaceutical Industry experience
• Experience working in a LEAN manufacturing environment.
• Project management skills.
• Knowledgeable in change management
• Proficiency with Microsoft Office Suite and have a working knowledge, or the ability to learn, computer systems.
• Lean/Six Sigma experience

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.