Facilities Engineer III
Company: Resilience
Location: West Chester
Posted on: April 18, 2024
Job 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 Position Summary &
Responsibilities
- May provide leadership, direction, and control for all
activities on small projects or portions of large projects within
the areas of design, architecture, and engineering
- Coordinates the work of skilled staff and consultants with
particular emphasis on meeting current schedules, budgets, business
plans, and long-range strategies of the organization
- Executes or assists in the execution of approved plans,
ensuring projects or portions of a project are completed in an
efficient, cost effective, and timely manner, and in support of
overall goals of the organization
- 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
Qualifications1. Experience supporting Facilities Engineering
within a regulated cGMP environment2. Project Management
ExperiencePreferred Qualifications1. 4-year Degree in Engineering2.
Masters Degree in Engineering3. SAP/Maximo CMMS Experience4. 5
Years experience supporting Facilities Engineering within a
regulated cGMP environment5. 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#LI-RM1Resilience 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 $75,000.00 - $112,500.00 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.
Keywords: Resilience, Hamilton , Facilities Engineer III, Engineering , West Chester, Ohio
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