Specialist IS Analyst

Specialist IS Analyst    Reference:  TPS123
SALARY Negotiable   LOCATION Ireland, Dublin
JOB TYPE Permanent   DATE POSTED 24/09/2019
INDUSTRY Pharmaceutical      
         
DESCRIPTION        
 

Client:  Systems integrator for Automation Systems in the pharmaceutical, Bio Pharma, food & beverage, utilities, power and built environment markets.

End client: Bio Pharmaceutical manufacturer based in Dublin.

 

Role Summary: Provide support for existing Quality and Laboratory information systems. 

 

Role Requirement:  The chosen candidate would typically be accountable for the following activities (but not exclusively): Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports.

• Manage any required contracts with vendors or third parties and ensure all parties are aware of their responsibilities.
• Ensures that systems are robust, reliable and available to meet business demand.
• Ensures that systems are maintained in a compliant manner according to the IS quality system.
• Ensures systems have appropriate disaster recovery plans and processes including contingency plans.
• Proactively engage with Quality and Laboratory teams to encourage the use of technology to maximise efficiency, capacity and reliability or operations.
• Develop innovative approaches to solve business challenges with current or new technology.
• Plan and execute Quality & Laboratory information systems projects.
• Coach system users in the complaint and efficient use of their systems.
• Aligns with relevant corporate business and IS teams to ensure that IS strategy for Quality and Laboratory systems is aligned with end-clients goals and standards.

Candidates should demonstrate technical, project and interpersonal skills, including but not limited to the following: client interfacing and resolution of client concerns, project definition and business case development, proactive support and resolution of issues, technical guidance from concept to delivery, system delivery, commissioning and validation.

 

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

 

Charlie Burgess +442081236574 UK & Ireland Agent  

CSV Engineer

CSV Engineer    Reference:   TPS121
SALARY Negotiable   LOCATION Grangecastle, Ireland
JOB TYPE Permanent   DATE POSTED 23/09/2019
INDUSTRY Pharmaceutical      
         
DESCRIPTION        
 

Client; Industry leading systems integrator for Automation Systems in the pharmaceutical, food & beverage, utilities, power and built environment markets.

 

Role Summary; CSV Engineer

 

Role Requirements: The chosen candidate would typically be accountable for the following activities (but not exclusively): 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

Basic Qualifications: 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 5 years’ experience validating IS Automation systems for manufacturing organizations in the biotechnology or pharmaceutical industries.
• Candidates should have experience using a paperless validation system such as HP ALM.
• Experience in the validation of one or more of the following system types from project conception to delivery; DCS/SCADA/MES/Historian

 

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

 

Charlie Burgess +442081236574 UK & Ireland Agency  

Delta V Engineer

Delta V Engineer    Reference:  TPS113
SALARY €55,000 +   LOCATION Ireland, Cork
JOB TYPE Staff   DATE POSTED 08/07/2019
INDUSTRY Pharmaceutical      
         
DESCRIPTION        
 

Client: Provider of complete automation solutions for the process and manufacturing industry. Key emphases includes the design of control and process control systems and the vertical integration of these systems in the overall corporate process.

 

Role summary: Automation engineer/Senior Automation Engineer will be involved in the design, configuration, implementation, testing, commissioning and validation of Pharmaceuticals client projects as well as day-to-day support and maintenance of the client automation systems. The successful candidates would be required to have a minimum of 5+ years’ pharma/biotechnology and Emerson DeltaV DCS experience.

 

Role Requirements: The chosen candidate would typically be accountable for the following activities (but not exclusively);

  • Experience implementing Emerson DeltaV automation solutions for clients in the Pharmaceutical and/or Biotechnology industries.
  • Full Delta V upgrade experience.
  • Good knowledge of GAMP lifecycle and quality management processes employed in the pharmaceutical and biotechnology sectors.
  • Experience with design, development and testing of DeltaV DCS
  • Preparation of functional specification and design specification documentation, and testing of automation systems
  • Configuration and programming experience – CMs, EMs, Unit Classes, Recipes, Controllers and Graphics
  • Knowledge of virtualization is added advantage
  • Experience in supporting client/sites for NC, CAPA, Root cause analysis and automation Change control management
  • Good analytical & problem solving skills
  • Excellent communication skills
  • Must work well in a team environment
  • Self-starter who can get the job done despite obstacles
  • Requires a Bachelor’s degree or foreign equivalent in Chemical, Electrical or Bio-Process Engineering, or related field
  • Minimum of 3-8 years of progressive experience as an Automation Engineer, DCS Software Engineer or related occupation

 

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

 

Charlie Burgess +442081236574 Agent UK & Ireland  

CSV Engineer

CVS Engineer   Reference:  TPS081
SALARY Negotiable LOCATION Dublin, Ireland
JOB TYPE Contract DATE POSTED 04/03/2019
INDUSTRY BioPharma
 
DESCRIPTION
Client; Engineering company focused on Process Automation delivery of Process Automation Solutions to Global Brands. Distilleries | Breweries | Blending Plants | Food Production | BioPharma.

End client; BioPharma corporation.

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 Recruiter 02081236574 Agent UK