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

 

QA Specialist

QA Specialist   Reference: TPS072  
SALARY Negotiable   LOCATION Cork, Ireland
JOB TYPE 12 – 18-month contract   DATE POSTED 24/01/2019
INDUSTRY Pharmaceutical      
         
DESCRIPTION        
Client; Engineering company providing automation solutions from 10+ location globally. It serves chemical, pharmaceutical/biotechnology, automotive, food and beverage, oil/gas, energy, water/wastewater, and other industries.  locations in Europe, North America, and Asia. As of August 31, 2014, Process Automation Solutions GmbH operates as a subsidiary of ATS Automation Tooling Systems Inc.

End Client; Pharmaceuticals

Job Title: QA Specialist. Report: Manager QA

Department: QA (QA Manufacturing and Engineering Support Team)

Requirement:

  • Acts as the day-to-day QA project contact person for the Manufacturing and Engineering departments providing guidance / feedback on quality issues related to their respective area project activities.
  • Completes the review/ approval of Manufacturing and Engineering project documentation – in particular equipment/ process/ automation validation documentation.
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Actively contributes to continuous improvement initiatives.
  • Builds and maintains good working relationships with Engineering, Manufacturing and
  • Quality department personnel in particular.
  • Supports the preparation for regulatory and customer GMP inspections of the site in addition to performing and co-ordinating internal audits.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations to ensure they are implemented and accurately documented in a timely manner.
  • Participates in developing Standard Operating Procedures (SOP’s) to ensure quality objectives are met.
  • Provides guidance and technical knowledge to more junior staff.
  • Participates in site cross-departmental teams as the GSIUC QA representative – Attending associated meetings ensuring QA is represented & its concerns/ issues communicated, aiding in the identification of potential improvements and participating in discussions on issues/ queries on the associated systems/process.
  • Assists with the maintenance of programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
  • Ensures compliance with all site safety-related procedures and practices.

Key skills

  • Demonstrates proficient knowledge of FDA/EMA regulations, guidance and current Good Manufacturing Practices (GMPs).
  • Experience in the review/ approval of validation documentation essential.
    Demonstrates proficiency in MS Office applications (including Word, Excel and Power Point, Adobe, SharePoint) and ability to quickly learn new systems is required.
  • Demonstrates the ability to work effectively in a team environment, contributing to a positive and constructive attitude.
  • Demonstrates solid verbal, written, and interpersonal communication skills.
    Must be able to exercise judgment within generally well-defined and established procedures and practices to determine appropriate action(s).
    Demonstrates independent action and initiative in resolving issues.
    Demonstrates the ability to prioritise and meet deadlines.
    LEAN and Six Sigma philosophy are embedded in your day to day working.

Qualifications

  • Minimum of 6 years of relevant experience and a BSc.
  • Minimum of 4 years of relevant experience and a MSC.
  • Prior experience in a cGMP related industry is desirable, within Biopharmaceutical or Pharmaceutical industry preferred.
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