Process Specialist II, Filling Inline Inspection

Resilience • West Chester, OH

2d • $29 - $43

About The Position

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 The Process Specialist II works directly with the Process Lead and Operations team to drive standardization of processes, procedures, standard practices, and continuous improvement across the Process Execution Team (PET) with a focus on inline inspection. The Process Specialist II performs tasks in support of the pharmaceutical manufacturing processes and helps the Process Lead drive performance improvements. This role will lead the coordination and execution of inline retain inspection for product complaints for all product presentations. This a Day Shift position working Monday - Friday.

Requirements

• Experience in documentation in a cGMP environment
• Experience in a pharmaceutical or cGMP regulated environment.
• Knowledge/experience of Aseptic Filling within an Isolator or RABS environment.
• Knowledge/experience of product inspection in a pharmaceutical environment.
• Strong leadership and interpersonal skills, with the ability to lead and collaborate effectively across cross-functional teams, build relationships, and influence others to drive performance.
• Demonstrated adaptability and self-awareness, including the ability to ask thoughtful questions, actively listen, provide constructive feedback, coach others, and continuously learn across diverse functional areas.
• 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.
• Good attention to detail is required.
• Individual must be capable of keeping accurate records and performing mathematical calculations.

Nice To Haves

• Bachelor’s degree or equivalent Pharmaceutical Industry experience
• Experience working in a LEAN manufacturing environment.
• Project management skills.
• Knowledgeable in change management
• Lean/Six Sigma experience

Responsibilities

• Guide team on SOPs (Standard Operating Procedures), work instructions, and MBRs (Master Batch Records).
• Maintain an advanced knowledge of Inspection techniques, and processes.
• Train others on inspection process as required.
• 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 close 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.
• Perform manual visual, cosmetic, and physical inspection of material.
• Promptly escalate concerns to Process Lead or Manager/Supervisor as needed
• Must obtain and maintain visual inspection qualification.
• Must obtain and maintain ability to use material handling equipment such as motorized and manual pallet jacks, nonmotorized lifts.
• Perform batch record and GMP documentation entries.
• Maintain records and/or logs as required in the performance of job responsibilities.
• This will include mathematical computation where needed.
• 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).

Benefits

• 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, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees