Maintenance Engineer
Job
Actalent
Remote
$94,078 Salary, Full-Time
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Job Description
General Summary and Purpose:
The Maintenance Engineer is a core team member of the Facility and Equipment Operations (FAC) team. The Maintenance Engineer role will support day-to-day tasks and ongoing projects to make our business successful. Some of the key traits, but not limited to are: Assisting with ongoing projects, supporting internal & external customers, and constantly improving the FAC team. The role will perform all functions in compliance with Company Policies and Quality Systems.Duties and Responsibilities:
Leads/Oversees maintenance of equipment records system to support the GMP compliant cleanrooms and laboratories. Revises equipment Standard Operating Procedures (SOP) Schedules equipment service calls and regular calibrations performed by external service providers. Assist/Lead/Drive Cleanroom maintenance programs in accordance with our internal customers. Assist/Lead/Drive FAC department mini projects in accordance with stakeholders and desired outcome. Oversees and verifies that external service providers perform maintenance in line with internal and regulatory requirements. Support site service activities and requests. By providing service and documenting actions and updating team members. Interfaces with manufacturing/QC/logistics staff to schedule and perform equipment maintenance. Performs equipment relocations and Final Acceptance Test (FAT) of more complicated equipment. Performs equipment installations, required calibrations, and routine maintenance. Troubleshoots, track, and document to resolution emergent equipment issues to prevent delays to in-progress production. Performs equipment repairs or facilitates repair by an external service provider. Write or revise equipment and facilities qualification documents (IQ/OQ/PQ) Perform or oversees execution of equipment and facilities qualifications (IQ/OQ/PQ) Author QMS investigations and design of CAPA plans Implement CAPA plans. Track, trend, and analyze department metrics and KPIs. Propose continuous improvement projects based on analyzing department data. Conducts sourcing, on-boarding, and commissioning of equipment in conjunction with head of Facilities and departmental SMEs. Must be able to support off hours; evenings and weekends when tasks dictate the need. Assists in training and oversight of Maintenance and Validation Technician I & II team members. On call after hours to respond to equipment monitoring system alarms.Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.Job Requirements:
Able to lead projects independently. Be able to translate trouble shooting into standard work. Detail oriented. Strong written and verbal communication skills Organizational and multi-tasking skills Results driven and adaptable to irregular non-frequent events. Strong technical/troubleshooting skills Positive attitude, flexibility, and willingness to learn and work in a team environment.Job Specifications:
Cleanroom experience preferred, but not mandatory. 5+ years cGMP facility or equipment lifecycle management experience required 2 years equipment validation experience preferred Experience with working on projects and meeting deadlines for the success of the overall team. Experience with creating and updating product build work instructions (WI). NPI experience a plus. Associate degree (experience can be applied in leu of education) CMRP certification a plus Experience with CAPA and Change Control systems and management Proficient in Microsoft Office Must be able to lift up to 55 pounds at a time Job Type & Location This is a Contract to Hire position based out of Bothell, WA. Pay and Benefits The pay range for this position is $38.46 - $52.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Bothell,WA.
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