Senior Specialist II, Sterile Ops Training

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 :

The role is responsible for managing, coordinating, and supporting GMP and department training programs for the Sterile Operations Manufacturing & Process Execution Team. Programs designed for the Aseptic Training Center, such as the aseptic gowning initial qualification, aseptic new hire training, and aseptic OJTs, will be supported by this role. This role collaborates with department and line leaders to identify training needs and develop learning plans and materials for teams and individuals and supports staff training needs and serves as a key interface with the site Learning & Development and Training & Development teams. This position will require working in various Controlled / Non-Classified areas. This role ensures that staff are set up for success in their core duties, fosters a culture of safety and quality, and maintains training compliance. As part of its compliance responsibility, this role will support deviation root cause analysis, identify trends, and develop training curriculum to address the trends.

Responsibilities :

• Facilitate the department training program, which includes developing training matrices, conducting an annual review of the learning plan, and assigning learner roles, curricula, and training to employees.
• Facilitate new hire or initial gowning training and qualifications in the Aseptic Training Center (ATC). This includes supporting both internal and external training and designing new curriculum to address training needs.
• Provide aseptic coaching on the production floor ensuring aseptic behaviors are in alignment with Standard Operating Procedures (SOP).
• Collaborate with line teams to develop and review On-the-Job Training (OJT) deliverables, content, and assessment requirements to ensure quality and maintain consistency.
• Analyze training matrices to identify skill gaps and training gaps and recommend targeted training initiatives.
• Provide deviation triage root cause analysis support, review deviation trends, and design curriculum to address deviation trends.
• Track and report training performance and compliance metrics per agreed KPIs.
• Support new hires to ensure a positive on-boarding and training experience and that all training objectives are met.
• Schedule and coordinate instructor-led training (ILT) programs for the department as needed.
• Provide updates to the Manufacturing & Process Execution Team on staff training progress, needs, and training opportunities and initiatives.
• Collaborate with the site Learning & Development and Training & Development teams to build alignment and understand expectations on LMS work processes and training compliance.
• Ensure proper documentation is maintained to company standards in training documentation.
• Participate in continuous improvement activities to drive efficiency, quality, product delivery, and safety improvement.
• Work collaboratively within and across departments to ensure sharing of best practices and lean behaviors.

Minimum Qualifications :

Preferred Qualifications :

This position may also include the following conditions :

Aseptic Gowning Qualification

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.

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. Our target base pay hiring range for this position is $100,000.00 - $145,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

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.