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Facilities Engineer IV

National Resilience

National Resilience

west chester, oh, usa
Posted on Wednesday, May 22, 2024

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 & Responsibilities
This position provides engineering support and technical expertise for GMP and non-GMP, utility systems, and related equipment.

Job Responsibilities (Including Key Result Areas, Specific Accountabilities, Tasks, Etc.)

  • Supports and/or acts as Facilities work stream lead on Capital Projects..
  • Manage small- and mid-scale capital projects to ensure on-time and in-budget completion.
  • Coordinate the activities of third-party representatives.
  • Manage the design, implementation, and support of site-wide process automation, supervisory control, and data acquisition (SCADA) solution.
  • Understands and follows site specifications for all projects.
  • Participate in new equipment design specification.
  • Ensures good engineering and documentation practices are used during job activities.
  • Conduct troubleshooting activities to support Facilities utilities and systems.
  • Gather, organize, and communicate operational information to others.
  • Lead and coordinate investigations and studies with little supervision.
  • Use CMMS (Computerized Maintenance Management System) to manage logistics.
  • Provide leadership, development, and mentoring for others.
  • Identify temporary and permanent fixes to address issues.
  • Initiate appropriate actions when process deviations occur.
  • Mange and own change controls, corrective actions, impact assessments, change control action items, deviations, and periodic reviews.
  • Monitor records to ensure compliance with regulatory requirements.
  • Coordinate with representatives from other departments.
  • Attend team meetings to discuss progress, initiatives, and/or other matters.
  • Monitor equipment and/or systems for performance and problem indicators.
  • Perform data entry.
  • Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, and so on.
  • Wear gowning and PPE (Personal Protective Equipment) as required by specific activities.
  • Maintain equipment and systems along with their certification records.
  • Read and interpret diagrams, drawings, and other schematics.
  • Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
  • Support Facilities utilities and systems for issues or utilities improvements. .
  • Train others on systems, software, equipment, machines, procedures, and/or processes.
  • Answer compliance and process questions from others.
  • Communicate policies and procedures to employees.
  • Establish visual tracking and other tools to enhance audit readiness and trend analysis.
  • Lead process improvement activities and teams to meet strategic goals.
  • Communicate priorities and progress to team on a continuing basis.
  • Facilitate team meetings to discuss progress, initiatives, and/or other matters.
  • Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions.
  • Coordinate activities of support groups.
  • Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.
  • Interact with regulatory agency personnel during audits and inspections.
  • Monitor key performance indicators to meet strategic goals.
  • Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
  • Review and approve documentation needed for qualification of equipment and processes.
  • Write, review, and revise SOPs (Standard Operating Procedures) for maintenance of equipment, systems, and/or facilities.
  • Assist with recruiting/interviewing/evaluating prospective employees.
  • Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
  • Facilitate inter-departmental meetings to discuss matters involving the coordination of multiple departments.
  • Interact with other departments to implement corrective/preventative actions.
  • Participate in cross-functional teams to meet strategic goals.
  • Read technical publications and manuals and write associated procedures.
  • Collect, record, and report metrics.
  • Execute validation protocols for processes, equipment, packaging, and/or cleaning.
  • Generate validation protocols for processes, equipment, and/or packaging.
  • Assess and implement improvements in productivity, waste generation, quality and cost.
  • Provide input on the engineering of replacement parts.
  • Assist process engineering and managers with improvement projects .
  • Lead committees or groups of employees tasked with accomplishing some objective(s).
  • Conduct presentations (other than training) for different audiences.
  • Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
  • Coordinate qualification activities.
  • Create specifications for equipment.
  • Create, generate, type, proof, and distribute correspondences.
  • Design and deploy new machines.
  • Answer questions from others regarding parts, capital, sending parts out for repair, purchasing, and/or reliability.
  • Lead teams in root cause analysis sessions.
  • Manage small- and mid-scale capital projects to ensure on-time and in-budget completion.
  • Coordinate the activities of third-party representatives.
  • Manage the design, implementation, and support of site-wide process automation, supervisory control, and data acquisition (SCADA) solution.
  • Manage supplier activities during design, fabrication, installation, commissioning, and qualification.
  • Organize shutdowns and/or maintenance windows.
  • Oversee validation activities.
  • Perform gap analyses and assessments for integration.
  • Provide 24/7 "on-call" support to others.
  • Provide, verify, measure, and revise drawings.
  • Recommend compliance resolutions to management.
  • Review and approve requirements, specifications, drawings, coding procedures, and guidelines

Minimum Qualifications

  • Experience supporting facilities engineering within a regulated or GMP environment
  • Prior experience in Maintenance or Technical Documentation
  • Strong Interpersonal Skills, Self-Motivated
  • Strong Organizational Skills
  • Strong communication skills, written and verbal skills
  • Strong leadership skills

Preferred Qualifications

  • Bachelor’s degree in engineering
  • Master’s degree is desirable
  • Experience utilizing CMMS
  • 7-10 Years Engineering experience in GMP environment.

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 equity, 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 $95,000.00 - $136,250.00 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.