Process Specialist II, Filling Inline Inspection

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.

Job 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).

Minimum 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.

Preferred Background

• 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

Key Relationships to Reach Solutions

Internal

• PET & other PETs (including other PET Supervisors/Managers)

• Technical Manager and Team Members

• Quality Assurance

• Cross-functional teams

External

• Other Supply & Demand Sites OEM suppliers

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

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.

As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.