NCBiotech Jobs Board ● Connecting North Carolina's life science employers and workforce.

Job: Lead Manufacturing Maintenance Lyophilization Technician, Alcami, Morrisville, NC

General Information


Job title:
Lead Manufacturing Maintenance Lyophilization Technician
Job location:
Morrisville, NC  27560 United States
Requisition code:
Date posted:
01/08/2021
Compensation:
Job category:
Other
Employment type:
Full time

Job Description


Position Summary



The Lead Lyophilization Maintenance Technician is responsible for the monitoring, operations, troubleshooting, and repair of all utilities and supporting equipment for the Lyophilizers. The position will be accountable for driving results in a fast-paced environment by leading and training Manufacturing Maintenance Technicians on pertinent SOP’s, Computerized Maintenance Management Software CMMS, technical information, and proper maintenance techniques in a cGMP environment. The position performs maintenance, testing, troubleshooting, and repair on facility, support systems, laboratory and manufacturing equipment. The position works on assignments that are extremely complex in nature in which independent action and a high degree of initiative are required in resolving problems and developing recommendations. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.



 



Essential Functions



 




  • Initiate major repair to the equipment to obtain maximum performance.

  • Capable of working alone with little or no direction.

  • Perform troubleshooting and repair on all type of breakdowns.

  • Perform project work that includes an abundance of plumbing and silver solder work.

  • Identify potential problems prior to them creating a breakdown.

  • Capable of performing all preventive maintenance functions alone.

  • Rebuild compressors, pumps, etc without assistance.

  • May be responsible for training activities related to new team members within Maintenance.

  • Ability to allign machines and equipment, using hoists, jacks, hand tools, and forklifts.

  • Connect power unit to machines or steam piping to equipment, and test unit to evaluate its mechanical operation.

  • Repair and lubricate machines and equipment.

  • Starts devices to test their performance.

  • Specifies and requests purchase of components, equipment and spare parts.

  • Interacts with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, validation.

  • Provides hands-on assistance to manufacturing processes.

  • Performs preventive and corrective maintenance on instrumentation, support systems, facility, utilities, and manufacturing equipment.

  • Completes or reviews all required supporting documentation related maintenance on support systems, facility, utilities, and manufacturing equipment.

  • Assists in the performance of validation protocols for support systems and production equipment.

  • Leads and trains Instrument Engineers on pertinent SOP’s and proper maintenance techniques.

  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

  • Analyzes wear of components and takes proactive steps such as implementing new PM’s, recommending replacement parts, or retrofit equipment.



Education and Experience




  • Associate’s degree or Bachelor’s degree in Life Science with 5+ years of related experience or High School Diploma with 8 – 13+ years of experience.

  • Must have demonstrated leadership and training skills.

  • CFC Certification



 



 



Alcami Non-Negotiables




  • Consistently demonstrates honesty and integrity through personal example.

  • Follows all safety policies and leads by example a safety first culture.

  • Produces high quality work product with a focus on first time right.

  • Complies with the company code of conduct and policies and regulatory standards.



 



Alcami Core Leadership Competencies




  • Passion for customers.  Understands Alcami customers.  Gets to the heart of the matter.  Uses that insight to provide value.

  • Thinks strategically.  Quickly identifies and acts on opportunities.  Combines forethought with action. Understands the external and internal environment and the impact on Alcami. 

  • Acts decisively.  Makes and acts on decisions quickly.  Fosters the same in others and the courage to enhance risk-taking for the business.

  • Drives performance.  Holds self and others accountable.  Creates an environment that enables others to perform at their best.

  • Works collaboratively.  Actively creates and promotes cross-boundary collaboration to achieve better results.

  • Develops organization and people.  Demonstrates genuine commitment to develop self and others.



 



Functional Competencies




  • In depth knowledge of water, HVAC, Steam, Boiler, Compressed Air and Chill Water systems.

  • In depth knowledge of Controls and Automation.

  • In depth knowledge on Electronics, Pneumatics, Hydraulics, Plumbing, and Mechanics.

  • Strong Knowledge of equipment used in pharmaceuticals manufacturing.

  • Knowledge of FDA, DEA, OSHA regulations.

  • Knowledge of SOPs, Change Management.

  • Knowledge of and ability to utilize a Computerized Maintenance Management System (CMMS) and Calibration Program Management.

  • Knowledge of and ability to utilize Microsoft Office Suite (Word, Excel, etc.).

  • Excellent communication skills (oral and written).

  • Ability to work independently.

  • Excellent mechanical skills.

  • Good problem solving skills.

  • Ability to train and mentor others.

  • Demonstrated leadership skills.



 



Travel Requirements




  • Up to 5% travel required.



 



What We Offer You:




  • Competitive salary with career advancement opportunities

  • Profit sharing bonus plan

  • Medical, dental and vision coverage from day one

  • 401(k) with company match

  • Company paid vacation, holiday and sick-leave

  • Voluntary benefits including short & long term disability, life, accident, critical illness insurances



 

Job Requirements


(see job description above)
(Job number: 3981275)
Do you know someone who would be interested in this job?   Tell them about it.