Aerie Pharmaceuticals has a job for you

 

Job Details


Manufacturing


Maintenance Technician, Sterile Ops  Athlone,   : 9/26/2022
Job Description

Job ID#:

295

Job Category:

Manufacturing

Position Type:

Employee


Details:

Overall Purpose:  
The Sterile Operations Maintenance Technician provides essential maintenance and technical support to manufacturing across the full range of sterile manufacturing equipment. The role involves developing preventative maintenance (PM) routines, completing PMs on time in addition to reacting to machine breakdown in support of manufacturing performance. The role also plays a significant role in ensuring all equipment related documentation meets the cGMP standards expected.

Essential Duties, Functions and Responsibilities:
  • Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
  • Prioritises safety and is diligent in the use of all appropriate safety tools and permits when maintaining equipment - champions safe working always.
  • Provides maintenance support as required to include process systems, filling equipment, preparation equipment and clean utilities. Can provide basic automation and instrumentation support and liaises with automation/instrumentation specialists when required.
  • Uses structured problem solving in the event of equipment failure and documents all equipment interventions as required by the maintenance system.
  • Prepare preventative maintenance (PM) routines with other technical colleagues to minimise the risk of machine failure or equipment related deviations. 
  • Completes PM routines on time.
  • Is trained and qualified to work in a grade B cleanroom and maintains this qualification.
  • Is disciplined in ensuring personal hygiene at all time, and in following the garbing and hygiene expectations of working in a sterile manufacturing environment.
  • Participates in bi-annual media fill studies to maintain qualification status.
  • Is diligent in the completion and review of maintenance and related documentation required to meet GMP requirements of a sterile manufacturing site.
  • Participates in and can lead continuous improvement teams. Proposes improvement ideas.
  • Takes ownership of manufacturing equipment performance and builds relationships with key OEM support contacts.
  • Supports capital projects throughout equipment lifecycle and supports process development projects and associated validation activities.
  • Reports accurately on all equipment downtimes to build history of equipment performance.
  • Is always prepared to escalate any safety, quality or performance risk observed.
  • Participate in out of hours on call as required.

Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

 
Job Requirements

 
Details:

Skills/Knowledge Required:
  • Familiar with pharmaceutical equipment and systems such as CIP/SIP, autoclaves, filling machines, isolators, and environmental monitoring systems.
  • Precision minded technician with demonstrable capability in equipment setup, optimisation and maintenance.
  • Strong technical, troubleshooting and problem-solving skills.
  • Proficient in use of Microsoft Office and other computer applications i.e. CMMS(PEMAC).
  • Strong team player with good proactive approach & manner
  • Knowledgeable of the regulatory and GMP requirements for maintenance activities.
 
Education Required: 
  • Ideally trade qualified in a mechanical fitting or as an electrician.
  • Mechanical/Chemical Engineering Diplomas will be considered if the candidate as proven experience in a pharmaceutical maintenance role.
 
Experience Required:
  • 8 years+ experience performing maintenance on process equipment in a cGMP commercial environment, preferably with experience working in a cleanroom environment.

Work Environment/Hazards and Physical Demands:
There is high physical demand in this role due to the nature of working, for extended periods, in a grade B cleanroom environment. The successful candidate must also have the flexibility to work with a complex filling process through glove ports and to garb into grade B attire while minimising microbial risk to the facility.  While performing the duties of this job, the employee is regularly required to use hands to manipulate objects or controls and to sit, talk, see, and hear.   The employee is frequently required to reach with hands and arms, stand, walk, and lift or move up to 5kg.  The employee is occasionally required to crouch. The employee will be expected to wear protective and/or safety equipment as needed.

This role may be a role on regular day shift but it is probable that this role is a shift role and the successful candidate will be expected to work in the shift pattern determined by the site. 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed above are representative of the knowledge, skills and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Travel:
 
The role will typically require infrequent, off site national and international travel, for training or new equipment testing, including overnight stays, up to 10% of the time. However, during the initial start-up phase of the manufacturing facility project, this may be as high as 30-50% for the first 12 months.




 

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