Validation Engineer

CSV / Serialisation / Aggregation    Reference:  TPS112
SALARY Negotiable   LOCATION Ireland, Dublin
JOB TYPE Contract (12 months) / Staff   DATE POSTED 05/07/2019
INDUSTRY pharmaceutical      
         
DESCRIPTION        
Client: Engineering company delivering system integration in the area of industrial automation in Ireland. Office based in Grangecastle. Offers a full spectrum of related services including system development, upgrades, technical support, project management and validation consultancy.

 

Role Summary: Validation Engineer to have CSV knowledge and the ability to manage the validation of a packaging serialisation & aggregation project. The role is at equipment and systems interface level primarily dealing with validation of line level equipment and interfaces to corporate SAP level.

 

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

  • Use knowledge of FDA cGMP and related regulations and guidelines and specific knowledge of validation methodologies and principles to perform validation on a variety of systems.
  • Co-ordination of site validation activities as per corporate Software Development Lifecycle and internal Quality Management systems.
  • Lead the project validation stream for the relevant projects.
  • Validation of line level UPI equipment.
  • Validation of SAP <-> MES (Manufacturing Execution Systems) interface.
  • Validation of Serialisation and Aggregation Solution <-> SAP interface.
  • Validation of Downtime Management System (DMS) -> SAP interface.
  • Preparation, review, execution and approval of validation documents and associated deviations/NCRs for computerised systems.
  • Analysis of results of testing and determining acceptability of results against predetermined criteria.
  • Computer systems validation.
  • Ensure compliance with current industry regulations and guidelines relating to validation.
  • Advise and support project team on computer validation activities.

 

Qualification & Requirements

  • Third level Degree in a relevant discipline.
  • Minimum of 5 years’ validation experience in the Pharma sector.
  • CSV experience is desirable.
  • Experience of QA in a FDA regulated environment also desirable.
  • Project planning experience a distinct advantage.
  • Past experience writing, reviewing and executing validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report).
  • Good understanding of Production Applications (e.g. MES, LIMS) with focus on interfaces.
  • Experience with SAP is a plus.
  • Experience with validating serialisation/aggregation solutions is an advantage.
  • Experience in risk assessments in relation to validation activities.
  • Technical writing experience.

 

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

 

Charlie Burgess +442081236574 Agent UK & Ireland  

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

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