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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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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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  

(Intermediate) Control Systems Engineer

Intermediate Control Systems  Engineer   Reference: TPS015  
SALARY Negotiable   LOCATION Dublin, Ireland
JOB TYPE Staff   DATE POSTED 12/08/2019
INDUSTRY Pharma/Bio      
         
DESCRIPTION        
 

Client: Engineering company offering controls, and validation solutions to manufacturing facilities across Ireland & Europe. Innovative approach to Automation, Involving in implementing Industry 4.0 and Smart Factory technologies. A rapidly growing, exciting, and fast-moving sector.

 

Role summary: As a Control Systems Engineer, your role will be the development, commissioning and support of automation and control systems. You will be responsible for automation and control systems design, specification, programming, simulation, testing and start-up assistance.

 

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

  • Software development of bespoke manufacturing systems.
  • Acquire a detailed understanding of the client’s automation systems (distributed control systems, programmable logic controllers, SCADA systems).
  • Ability to interact with the customers on technical requirements.
  • Ability to assess existing technologies and process.
  • Ability to design robust solutions.
  • Investigate and provide technical advice and support to manufacturing and other engineering disciplines on automation related issues.
  • Operate according to SOP’s developed for site engineering and maintenance.
  • Partner with different disciplines to deliver automation projects in accordance with GAMP guidelines.
  • Generate documentation and SOP’s associated with each of the Automation systems as required.

Proven experience with one or more of the following technologies will be an advantage:

  • Allen Bradley (Logix 5000)
  • Siemens (Step7)
  • Delta V DCS
  • MES
  • .Net, C#, Java, SQL (MS entity framework), Web Services (WCF), Azure DevOps:

 

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Charlie Burgess +442081236574 Agent UK & Ireland  

Senior Controls Engineer

Senior Controls Engineer   Reference:  TPS120
SALARY Negotiable   LOCATION Dublin, Ireland
JOB TYPE Staff   DATE POSTED 08/08/2019
INDUSTRY Pharmaceutical

BioTech

     
         
DESCRIPTION        
 

Client: Engineering company offering controls, and validation solutions to manufacturing facilities across Ireland & Europe. Innovative approach to Automation, Involving in implementing Industry 4.0 and Smart Factory technologies. A rapidly growing, exciting, and fast-moving sector.

 

Role Summary: As a Senior Control Systems Engineer you will operate as an active member of the Engineering team and will have a responsibility to mentor more junior resources in the group based on your years of experience.

 

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

  • You will have an elevated position of authority as a Senior Engineer and will be required to give direction, inspiration and technical knowledge to fellow and junior resources.
  • Your role will involve the development, commissioning and support of automation, control systems and custom developed software programs.
  • You will be responsible for automation and control systems design, specification, programming, simulation, testing and start-up assistance.
  • You must possess the technical expertise to maintain, develop, troubleshoot and validate these systems in a compliant and competent manner
  • You will be required to self-manage agreed project goals and interact with the customer to achieve these goals
  • You should be at a sufficient level of expertise to take front line interactions with the customer for assigned project work and possess the ability to report to management on progress and any road blocks that present themselves over the course of your duties
  • You will also be required to manage the delivery of project development work and goals assigned to junior and fellow engineers if requested
  • You will require strong software development skills across multiple platforms to accommodate the vendor neutrality that currently exists. Over the course of the role you will be expected to specialise in a core group of platforms to be agreed with management and to become a system expert in those platforms for the overall group
  • You will be responsible for always representing the company in a positive light with potential and current customers and where possible interacting with the customer and management to potentially acquire and procure new work and new opportunities.
  • You will have demonstrated the ability to become a code designer in at least one software platform, i.e. Allen Bradley PLC, SQL
  • You must have proven experience in PLC logic and programming with one or more of the following PLC’s, programming languages or SCADA systems:

 

  • Allen Bradley (Logix 5000)
  • Siemens (Step7)
  • Elau
  • Bosch
  • Omron
  • Modicon
  • GE Fanuc
  • B&R
  • Mitsubishi
  • VB
  • SQL
  • Wonderware InTouch
  • RS View
  • Siemens
  • Labview
  • GE Cimplicity

 

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Charlie Burgess +442081236574 Agent UK & Ireland  

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

 

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Charlie Burgess +442081236574 Agent UK & Ireland  

Senior Automation Engineer

Senior Automation Engineer   Reference: TPS083
SALARY €70,000+   LOCATION Dublin, Ireland
JOB TYPE Permanent   DATE POSTED 18/03/2019
INDUSTRY Pharmaceutical

Medical Devise

     
         
DESCRIPTION        
Client: Pharmaceutical corporation operating a BioPharma facility in Dublin.

 

Requirement

Senior Automation Engineer , internally known as a Specialist IS (Information Systems) Automation Engineer, to join the Automation Engineering team reporting directly to the Senior Manager of Information Systems.

As a senior member of the Automation Engineering team, the Specialist will support complex and challenging process automation initiatives that require understanding of analytical problem-solving techniques, project management, life-cycle management and Operational Excellence. Additionally, the Specialist is responsible for providing project leadership and daily operational support to the Automation Engineering team at the site.

 

Responsibilities

  • Leads and supports of capital projects
  • Facilitates the application of advanced automation engineering principles in the design, specification, construction, startup, and validation of process and GMP utilities equipment and systems for capital projects of significant scope and complexity.
  • Leads and supports technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems
  • Leads and supports new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs
  • Devises new approaches to complex problems through adaptations and modifications of standard automation technical principles
  • Works closely with multiple disciplines, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to manage a diverse portfolio of projects.
  • Provides technical support to commercial and clinical manufacturing as needed.
  • Develops and executes strategic initiatives for long-range planning and lifecycle upgrades of various Automation platforms with activities including managing a 5 year roadmap of systems, presenting high level scope and cost estimates to executives for annual capital funding plan, and project management of initiatives once approved for execution
  • Provides mentorship to Automation Engineering team in daily operations
  • Communicates proactively with multiple levels within the organization, highlighting issues and proposing solutions

 

Qualifications

  • Bachelors Degree or Masters Degree in Chemical or Electrical Engineering or related technical field
  • 5+ years experience in Process Automation Engineering in a manufacturing support environment with at least 3+ years experience in the Pharmaceutical or Biotechnology industries
  • 5+ years combined experience with the following product platforms: Rockwell systems and/or Emerson DeltaV DCS systems
  • 5+ years experience with building automation systems with preference to Siemens Apogee or Desigo platforms
  • Programming expertise with SCADA, PLC, HMI, and wed based applications
  • Familiarity with industry standards for batch control systems, software development life cycle methodologies, S88, 21 CFR Part 11, Validation, and GAMP
  • Strong control system automation background. Design, installation, programming and validation of automated processes
  • Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services and non-GMP Utilities preferred

 

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Charlie Burgess Recruiter 02081236574 Agent UK & Ireland

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

Graduate Automation Engineer

Graduate Automation Engineer   Reference: TPS070  
SALARY €25,000   LOCATION Cork, Ireland
JOB TYPE Permanent   DATE POSTED 11/01/2019
INDUSTRY Pharmaceutical      
         
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; Pharmaceuticals corporation.

Responsibilities

Automation and controls systems project management towards specification, design, start-up, and commissioning in a cGMP environment.

Essential Duties and Responsibilities include, but are not limited to, the following whilst under the supervision/mentorship of Senior staff:

  • Manages projects related to design, commissioning, and performance improvement of automated equipment.
  • Provides design/approval of hardware, software, and controls for automated equipment.
  • Provides technical and automation operational support to Manufacturing and Facilities.
  • Implements software/hardware changes and upgrades, understands impact of actions to Manufacturing and Facilities.
  • Implements modification/change control procedures and protocols.
  • Supports Validation Department with initial design review, software testing, protocol execution and review.
  • Programs PLC and HMI application for automated process equipment, capable of troubleshooting and demonstrates knowledge of instrumentation and controls.

Education and Experience:

Requires BS/BEng or higher in Science, Engineering, Instrumentation or Software Programming. May substitute relevant experience for education.

Charlie Burgess Recruiter 02081236574 UK Agency Automation