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  

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

Validation Engineer

Validation Engineer   Reference: TPS065  
SALARY Negotiable   LOCATION Dublin, Ireland
JOB TYPE Contract (12 months)   DATE POSTED 08/01/2019
INDUSTRY Pharmaceutical      
         
DESCRIPTION        
Client; Systems Integrator focused on Process Automation Delivery of Process Automation Solutions to Global Brands.

End client focus; Distilleries | Breweries | Blending Plants | Food Production | BioPharma

Job Title; Validation Engineer

Responsibilities;  Ensuring that all manufacturing processes, packing operations, equipment, cleaning, utilities/facilities, computer and analytical methods are fully validated to meet the expected and operational requirements and GMP regulatory requirement. Must have the presence to promote the company image and ensure that this is enhanced by the successful implementation of systems.
This will be an interesting and varied role, and the opportunity to progress within the team will be available to the right candidate. Produce project documentation suite such as design documentation and test specifications and expected to review documents produced by junior engineers.
Essential Skills;

  • At least 5 years experience in Validation (ComputerSystem/Process/Project/Equipment/Cleaning etc.) within the Biotech/Med Device/ Pharmaceutical (FDA/MHRA regulated industries).
  • Strong cGMP, GAMP and GxP knowledge with knowledge of FDA 21 CFR Part 11, Annex 11 regulation.
  • Demonstrated understanding and hands-on experience generating and reviewing validation lifecycle documents.
  • Ability to discuss technical aspects of validation and GxP testing with clients.
  • Strong attention to detail regarding documentation is a must.
Charlie Burgess 02081236574 Recruiter Automation UK

Validation Engineer

VALIDATION ENGINEER   Reference: TPS004  
SALARY: Negotiable LOCATION: North West England
JOB TYPE: Permanent DATE POSTED: 01/03/2017
 
DESCRIPTION  INDUSTRY  Pharmaceutical
Responsibilities:

Leader in Industrial Automation requires a Validation Engineer who will be responsible for ensuring that all manufacturing processes, packing operations, equipment, cleaning, utilities/facilities, computer and analytical methods are fully validated to meet the expected and operational requirements and GMP regulatory requirements.

The suitable candidate must have at least 5 years’ experience in Validation (Computer System/Process/Project/Equipment/Cleaning etc.) within the Biotech/Med Device/ Pharmaceutical (FDA/MHRA regulated industries).