Aerie Pharmaceuticals has a job for you

 

Job Details


Manufacturing


Automation Engineer  Athlone,   : 8/24/2017
Job Description

Job ID#:

66

Job Category:

Manufacturing


Details:

The Automation Engineer provides instrument and control engineering support to the build-out, equipment procurement, commissioning, validation, and tech-transfer activities associated with the start-up of the new Aerie Ireland manufacturing facility.   For the on-going commercial operation of the facility, the Automation Engineer will provide plant wide support to existing control systems, to support the Maintenance and Manufacturing functions. The Automation  Engineer will report to the Technical Services Manager. 
Essential Duties, Functions and Responsibilities:
  • Liaise with design & construction management consultants on technical, quality, validation and cost issues.
  • Play integral role in the technical specification of control systems for process equipment based on end-user requirements (hardware & software).
  • Develop site wide automation strategies and standards.
  • Liaise with major equipment vendors to ensure compliance to specifications e.g. GAMP 4 and 21 CFR Part 11.
  • Development and/or review of URS for process control systems.
  • Review, progress and approve vendor and consultant documentation e.g. URS, FDS, FAT, SAT, and Operator Manuals.
  • Integration of critical high tech. process equipment under a single SCADA system in conjunction with solution provider.
  • Co-ordinate solution providers, engineering consultants, with Aerie project teams towards a successful integration, testing and validation programme.
  • Participate in the validation planning effort providing project specific information and support.
  • Play a key role in the review, approval and execution of validation protocols.
  • Lead equipment vendor Software FATs and SATs ensuring compliance and acceptability of plant software /hardware and documentation.
  • Maintain accurate and accessible project files and records e.g. project history files, comment tracking, etc.
  • Supports capital projects throughout equipment lifecycle.
  • Supports product or process development projects and associated validation activities.
  • Provides technical support and trouble-shooting in support of manufacturing, validation and maintenance activities.

 
Job Requirements

 
Details:

Skills/Knowledge Required: 
  • Requires excellent technical knowledge with good operational and/or project engineering experience i.e. all phases of the GAMP life cycle, validation phases, final hand-over and training.
  • In-depth knowledge of control system validation FAT to PQ (protocol generation, review, execution and reporting).
  • In-depth knowledge of GAMP 4/cGMP requirements.
  • Siemens S7 PLC (or similar control systems) and SCADA experience.
  • Strong analytical skills and documentation skills.
  • Strong understanding of relevant pharmaceutical industry regulatory requirements.
  • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently
  • Strong team player.
  • Good proactive approach & manner
Education Required:
  • Bachelor’s Degree in Engineering (Electrical, Electronic, Mechanical or Chemical)
  • Additional qualification and/or Master’s degree an advantage.
 
Experience Required:
  • +12 years’ experience, with at least 8 years prior experience as an Automation Engineer in a pharmaceutical manufacturing environment.  
  • New facility start-up (plant commissioning and validation) experience desired.
  • Experience with PLCs and SCADA systems
  • Experience of data historian and MES systems
  • URS generation, FDS review, FAT/SAT protocol generation/review and Software FAT & SAT execution.
  • Experience of UMS, BMS and EMS systems – their specification, testing, commissioning and validation.
  • Experience of engineering consultant and solution provider co-ordination.
  • Experience of sterile vial fill and packaging line operations an advantage but not essential.
 
 
 
Work Environment/Hazards and Physical Demands:
The physical demands include those required of a normal office position and engineering shop floor support in a cleanroom environment.  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 is occasionally required to climb ladders to access technical areas. The employee must be capable of wearing sterile cleanroom garb in a grade B environment. The employee must be capable of wearing protective and/or safety equipment as needed.
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 business or equipment/project review meetings, 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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