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Facilities Engineer II

Resilience
Published
May 3, 2024
Location
8814 Trade Port Dr., Hamilton, OH, Ohio
Job Type

Description

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

  • Prepare documentation of activities, actions, and/or results.
  • Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
  • Complete required training.
  • Ensure proper documentation practices during job activities.
  • Perform visual inspections.
  • Conduct troubleshooting activities.
  • Gather, organize, and communicate operational information to others.
  • Lead and coordinate investigations and studies with little supervision.
  • Use MAXIMO and/or 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 action when process deviations occur.
  • 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.
  • Report process deviations when they occur.
  • Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
  • Coordinate preventative (scheduled) and corrective/emergency (unscheduled) maintenance of equipment, systems, and/or facilities without supervision.
  • Ensure proper cGMP documentation practices during maintenance processes.
  • 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.
  • Monitor routine sampling activities.
  • Monitor high purity water testing.
  • 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.
  • Participate in spill control, handling of hazardous materials, and first aid.
  • 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.
  • Close out deviations, CAPAs, and/or pAFCAs as needed.
  • 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.
  • Participate in new equipment design specification.
  • Read technical publications and manuals and write associated procedures.
  • Review and approve OCMs, change controls, and document revisions.
  • 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 change control activities.
  • 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 personnel.
  • Manage the design, implementation, and support of site-wide process automation, supervisory control, and data acquisition (SCADA) solutions.
  • Manage supplier activities during design, fabrication, installation, commissioning, and qualification.
  • Coordinate shut downs and/or maintenance windows.
  • Coordinate 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.
  • Serve as SME (subject matter expert) and/or primary point of contact for various safety initiatives (for example: quarterly departmental safety inspections, fire and light safety, industry safe program, process safety management program).

 

Minimum Qualifications
1. Experience supporting Facilities Engineering

2. Project Management Experience

Preferred Qualifications
1. 4-year Degree in Engineering
2. SAP/Maximo CMMS Experience

3. Experience supporting Facilities Engineering within a regulated cGMP environment

4. Clean Utilities Experience (WFI, USP, Clean Steam, CDA)

This position may also include the following conditions:

  • On-Call/Off shift Support
  • Perceiving Information with Speed and Accuracy
  • Following Instructions
  • Communicating Orally
  • Learning New Knowledge and Skills
  • Generating Creative Ideas
  • Making Decisions
  • Reasoning and Thinking Critically
  • Solving Problems
  • Troubleshooting
  •  Multi-Tasking
  • Perceiving Meaning and Messages
  • Memorizing
  • Concentrating
  • Analyzing and Understanding Systems
  • Performing Basic Mathematical Calculations
  • Using Mathematics to Solve Problems
  • Reading and Understanding Written Information
  • Reading and Understanding Technical Information
  • Communicating in Writing
  • Inspecting Objects or Processes
  • Visualizing Objects
  • Using Tables, Charts, and Graphics
  • Working with Data
  • Analyzing Data
  • Using Correct Spelling and Grammar
  • Thinking Strategically

 

To Apply:

https://resilience.wd1.myworkdayjobs.com/en-US/Resilience_Careers/job/Facilities-Engineer-II_R-104492?locations=4a551f6ebc421001f39dda4e939c0000

 

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 $60,000.00 - $90,000.00 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.

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