Senior Specialist II, Sterile Ops Training

Resilience•West Chester, OH

40d•$100,000 - $145,000

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 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.

Requirements

Prior Aseptic Manufacturing Experience
Ability to stand and deliver training curriculum and orchestrate an engaging learning environment
Knowledgeable about learning management systems, instructional design and e-learning platforms
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

Nice To Haves

Bachelor of Science in Administration, Education, Business, Engineering, Pharmacy, or related Science
Experience in a pharmaceutical production environment
Working knowledge of Veeva Vault and data analysis tools such as Excel and PowerBI
Experience working in a LEAN manufacturing environment
Knowledge of cGMPs and FDA policies/procedures

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.