Senior Systems Validation Engineer

Systems Validation Engineer   Reference:  TPS120
SALARY Negotiable   LOCATION Dublin (N/S), Ireland
JOB TYPE Contract (12 months)   DATE POSTED 12/08/2019
INDUSTRY        
         
DESCRIPTION        
 

Client: Leading Engineering company that provides Automation, Controls and Validation solutions to the Pharmaceutical/BioPharma/Medical Device manufacturing sector.

 

Role Summary: We currently require a Senior Systems Validation Lead/Engineer to join and take complete ownership to ensure conformance to quality systems, to liaise with various departments, and give guidance, review documentation and ensure the company validation policies & procedures are being adhered to.

 

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

  • Managing and co-ordinating the preparation, review and approval of the Validation Master Plans.
  • Managing and co-ordinating of all validation strategies and deliverables.
  • Development and maintenance of internal validation policies and procedures based on best international standards and practices.
  • Auditing of internal projects against internal validation policies and procedures.
  • Managing and co-ordinating the preparation, review and issuing of validation protocols and reports.
  • Managing and co-ordinating validation documentation including risk assessments, traceability matrices, and validation reports.
  • Managing and co-ordinating the review and approval of specifications associated with Equipment, Processes, Products and Computerised Systems.
  • Managing, co-ordinating and directing all validation and revalidation activities.
  • Reviewing, managing and approving change control forms for Validation/Compliance implications.
  • Managing and co-ordinating routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise
  • Updating existing quality documentation related to validation activities.
  • Identifying training requirements for project team members in support of validation.
  • Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline.
  • Over 5 years’ experience as a Validation Engineer (mainly computer validation) in the Pharmaceutical or related Healthcare industry.
  • Experience of GxP Computerised Systems.
  • Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.

 

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

 

Charlie Burgess +442081236574 Agent UK & Ireland  

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

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