CSV Engineer

CSV Engineer    Reference:  TPS085
SALARY Negotiable   LOCATION County Cork, Carringtohill
JOB TYPE Contract (12 months)   DATE POSTED 08/04/2019
INDUSTRY Medical Device and Equipment manufacturer      
DESCRIPTION        
Client; Medical Devise and Equipment manufacturing company.

Responsibilities

Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports.

  • Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
  • Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
  • Ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
  • Review and Approve validation protocols and assessments from a quality system documentation perspective.
  • Liaise with Engineering / Automation and external vendors regarding equipment documentation, HDS, SDS, FDS, User Requirement Specifications (URS’s), and any other associated validation issues.
  • Participate and communicate as required in project activities.
  • Develop procedures to manage computerised systems where required
  • Develop and present project plans to project management senior staff

Requirement

  • Bachelor of Science/Engineering degree or equivalent.
  • Knowledge of cGMP’s and other worldwide regulatory requirements.
  • Problem solving ability and excellent oral and written communications skills
  • Understanding of the computer system validation lifecycle

Preferred Qualifications

  • Candidates must have demonstrated experience in the delivery and management of IS / Automation systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 industry standards.
  • The successful candidate will have a least 3 years experience validating IS Automation systems for manufacturing organisations in the biotechnology or pharmaceutical industries.

 

Get in touch with us for full brief on this position.

 

Charlie Burgess +2081236574 Recruiter Agent in Automation UK & Ireland

PCS7 Engineer

PCS7 Engineer   Reference: TPS073  
SALARY Negotiable   LOCATION Holland, Amsterdam
JOB TYPE Contract (12 months)   DATE POSTED 25/01/2019
INDUSTRY Manufacturing      
         
DESCRIPTION        
Client; Solution Provider for Process Optimization, Advice & Automation

End client; Manufacturer in the Food & Beverage industry, Packaging line

Job title: Software Engineer

Responsibilities

  • Independently perform and implements controls-related project or manufacturing support tasks, which have a direct impact on company profitability.
  • Successfully execute multiple project or manufacturing support tasks in a cGMP environment; and understand regulatory and quality assurance requirements/impact.
  • A recognized authority in Siemens PCS7 automation platform (WinCC included).
  • Develop a general understanding of the plant processes and products to provide technical support to all manufacturing areas.
  • Understand electrical power and distribution systems, NEC codes, electrical installations, and electrical panel building.
  • Develop innovative design solutions to complex problems.
  • Develop a network of internal and external contacts appropriate to the job. When assigned, able to oversee (external) consultants.
  • Prepare and manages small to medium-sized Capital Projects.
  • Assist the department in developing policies, programs, SOPs, and Quality and Engineering standards to meet current industry, corporate Quality, and external regulatory requirements.
  • Maintains close contact with QA and Manufacturing groups to assure effective communication on process/facility problems and issues related to process controls.

Qualification Requirements

Education: BS Chemical, Mechanical or Electrical Engineering. In lieu of an Engineering degree, technical experience in a pharmaceutical or regulated industry may be considered.

Experience: 5+ years in pharma or process related in a regulated environment.

Charlie Burgess Recruiter 02081236574 Agent UK

Automation Systems / Controls Engineer

Automation systems / Controls Engineer – Beckoff essential   Reference: TPS071  
SALARY Negotiable   LOCATION Waterford, Ireland
JOB TYPE Contract (9 months)   DATE POSTED 22/01/2019
INDUSTRY Healthcare      
         
DESCRIPTION        
Client:  Systems Integrator focused on delivering automation, information technology / MES, and safety solutions.

End client; Medical Device manufacturer

Summary:  Suitable Automation Systems / Controls Engineer works with technical team members to maintain, repair, troubleshoot and develop systems architecture within allocated timeframes and cost constraints.

Requirement

  • Provide PLC programming, Visions Systems, SCADA systems installation, networks, set-up, configurations, calibrations, troubleshooting and fault finding support.
  • Support design, buy-off, installation and validation of automated production lines.
  • Be willing to travel as necessary to support equipment buy-offs and training at vendor/customer sites.
  • Lead systematic technical root cause investigations.
  • Support manufacturing IT Systems architecture.
  • Drive continuous improvement projects.
  • Manage assigned project budgets, liaise with customers, contractors as required.
  • Develop systems equipment maintenance procedures.
  • Develop and deliver technical systems training.
  • Support all company safety and quality programs and initiatives.
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes.
  • Ensure compliance with all learnings from all GMP training events
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/positions

Skillset

  • Able to work in a team environment.
  • Excellent organisation, communication and presentation skills.
  • Systematic troubleshooting skills.
  • Strong leadership of technical issue resolution.
  • Provide innovative solutions to complex problems.
  • Programming experience: PLC, C++, SQL.
  • Good data analysis skills.
  • Proficient in MS Office applications, experience of MS Project, MS Access.
  • CAD experience desirable
Charlie Burgess 02081236574 Recruiter Agent UK