Tag: GMP

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.

 

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Charlie Burgess +442081236574 UK & Ireland Agent  
by charlieepburgess

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

 

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Charlie Burgess +442081236574 UK & Ireland Agency  
by charlieepburgess

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.

 

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Charlie Burgess +442081236574 Agent UK & Ireland  
by charlieepburgess

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  
by charlieepburgess

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  
by charlieepburgess

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
by charlieepburgess

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

 

by charlieepburgess

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

 

by charlieepburgess

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
by charlieepburgess