Senior Facilities Coordinator

ResilienceWest Chester, OH
2d$24 - $37

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 The F&E Coordinator performs tasks in support of the Facilities and Engineering Department. Specific requirements include assisting with manufacturing investigations; issuance, revision, and authoring of documents. They are responsible for facilitating, coordinating, and supporting department training programs. This position will require working in various Controlled/Non-Classified areas. This role ensures that employees are set up for success in their core duties, fosters a culture of safety and quality, and maintains training compliance. Technical writing to include investigations, line assessments, and corrective actions. Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results using GDP where applicable. Author/Approve/Review/Revise/Audit SOPs, Work Instructions. Read technical publications and manuals and write associated procedures. Review documentation needed for qualification of equipment and processes. Guide team on SOPs (Standard Operating Procedures) and work instructions. Communicate policies and procedures to employees. Lead training on all document modifications prior to effective date, as needed. 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. 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. Track and report training performance and compliance metrics per agreed KPIs.

Requirements

  • Experience in documentation in a cGMP and/or a regulated environment.
  • Experience in a pharmaceutical, cGMP, and/or regulated environment.
  • Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
  • Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.

Nice To Haves

  • Experience in a production environment
  • High school graduate, vocational school graduate or equivalent, Bachelor’s degree or equivalent
  • Experience working in a LEAN manufacturing environment
  • Knowledge of cGMPs and FDA policies/procedures

Responsibilities

  • Assisting with manufacturing investigations
  • Issuance, revision, and authoring of documents
  • Facilitating, coordinating, and supporting department training programs
  • Technical writing to include investigations, line assessments, and corrective actions
  • Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results using GDP where applicable
  • Author/Approve/Review/Revise/Audit SOPs, Work Instructions
  • Read technical publications and manuals and write associated procedures
  • Review documentation needed for qualification of equipment and processes
  • Guide team on SOPs (Standard Operating Procedures) and work instructions
  • Communicate policies and procedures to employees
  • Lead training on all document modifications prior to effective date, as needed
  • 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
  • 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
  • Track and report training performance and compliance metrics per agreed KPIs

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