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Equipment Specialist in Summit, NJ at APEX Systems

Date Posted: 5/17/2019

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Summit, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    5/17/2019

Job Description

Job #:  970805


Responsibilities:
  • Executes equipment calibrations, maintenances, repairs, and requalification activities in both laboratory and manufacturing areas. 
  • Supervises vendors for Calibration, preventative maintenance, and qualification functions. 
  • Reviews and approves vendor executed calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to internal standards. 
  • Works closely with, and enters data into the site CMMS system. 
  • Ensures all calibration, PM, and qualification records are filed appropriately after approval. 
  • Writes and supports deviations and investigations that result from qualification failures along with developing and supporting the implementation of corrective and preventative actions. 
  • Support the development, revision and review of written procedures for calibration, preventive maintenance and requalification of equipment. 
  • Support the development, review and approval of calibration and maintenance plans in site CMMS system. 
  • Addresses BEMS equipment alarms and ensures storage equipment maintains the appropriate set points. 
  • Supports the execution of equipment qualifications and process improvement studies. 
  • Adheres to all policies and procures which govern the ECQ team and the equipment they manage in order to ensure compliance is held to the highest standard. 
  • Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests. 
  • Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met. 
  • Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment. 
  • Work with planning group to ensure CMMS system is updated as calibration, maintenance and requalification activities are performed. 
  • Maintains all required Corporate, Facilities and EHS training as required. 
  • Adheres to all safety procedures and hazard communication. 
  • May be called upon to act as Subject Matter Expert in both internal and regulatory audits. 

Qualifications: 
  • BS in Engineering or Science related discipline preferred. 
  • 5+ years’ experience in GMP laboratory or manufacturing environment / regulated industry required. 
  • 2-3 years' experience working with and troubleshooting single use biologics manufacturing equipment, such as bioreactors, chrom skids, and tangential flow filtration skids. 
  • Experience writing and supporting deviations and investigations preferred. 
  • Experience working with CMMS systems, mainly Blue Mountain RAM preferred.
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. 
  • Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. 
  • Strong written and verbal communication skills. 
  • Excellent interpersonal skills with experience dealing with a diverse workforce. 
  • Strong multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
  • Ability to effectively manage multiple tasks and activities simultaneously. 
  • Proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business. 
  • Ability to interact effectively with laboratory, QA, and Facilities groups. 

 
 
 
 
 
 
 
 
EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.