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

Automation Engineer

Automation Engineer   Reference:  TPS082
SALARY Negotiable LOCATION Dublin, Ireland
JOB TYPE Contract (12 months) DATE POSTED 05/03/2019
INDUSTRY BioPharma
 
DESCRIPTION
 

Client; Supplier of Control Integration Services with 5 core focus area’s; Controls System Integration, Cyber Security for ICS, IOT, Functional Safety & 24/7 support.

 

End client; Pharmaceuticals corporation.

 

Responsibilities;

 

• Responsible for delivering automated solutions.

• Designing, coding and testing automation software solutions.

• Working closely with the Process Design Engineers and other project team members to meet key software delivery requirements and milestones.

• Design, develop and test software code in accordance with site coding standards and adherence to good engineering practice.

• Ability to read and understand P&IDs and Process Descriptions for various plants,       processes, and/or equipment.

• Design, program, implement, test and document process control applications.

• Understanding and implementing the validation life cycle for automated systems.

 

Qualifications;

 

• Degree qualified, experienced automation engineer with a minimum of 3 years experience.

• Knowledge of Siemens and/ or Rockwell automation platforms.

• Experience with automation system implementation and validation.

• Experience in some the following: Automation applications from Siemens S7, Rockwell and/or Wonderware, PLC Controls, Siemens and/or Allen Bradley, WinCC, PCS7.

• Experienced in all of the following project phases: Requirements documentation, detailed design generation, implementation, system integration, testing and on-site commissioning.

 

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

 

Charlie Burgess Recruiter 02081236574 Agent UK

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

 

Senior Controls Engineer

Senior Controls Engineer    Reference:   TPS078
SALARY £60,000 +   LOCATION UK, Reading
JOB TYPE Staff   DATE POSTED 14/02/2019
INDUSTRY Materials handling      
         
DESCRIPTION        
Client: leading provider of sophisticated automated material handling solutions for  retailers, manufacturers and logistics providers globally.

Responsibilities: Design, develop and integrate complex software functions within client’s established Automation department. You will be an active and integral member of a team to achieve the completion of set tasks. You will also generate innovative solutions in work situations to deal with problems and opportunities.

  • Testing, verification, and validation of PLC Software
  • Test and Certification of PLC Software
  • PLC Software architecture and coding
  • PLC Software development
  • Act as technical interface with customers, establishing professional relationships to ensure that the project requirements are fully defined and agreed.
  • Ensure that required prerequisites (e.g. design inputs, tools, documentation, deliverables, schedule, and budget) are in place prior to commencing work.
  • Shares technical knowledge with project team, supervisor, own discipline and other engineering disciplines.
  • Attend all project related turnover meetings and functional design reviews.
  • Design efforts in line with program requirements and standards.
  • Ensures proper test plans (Internal, In-House, Site, Commissioning, and Acceptance) are crafted.
  • Review and consult on open issues; assists with any customer customer concern.

Required

  • Bachelor’s degree in Engineering, or Similar qualification HNC, or HND.
  • Understanding various software development lifecycle.
  • Experience with Siemens, Rockwell PLC platforms.
  • Experience of working in the Automation industry.
  • Demonstrate the ability to develop efficient and high quality software.
  • You will have understanding of the software development lifecycle.
  • Effective communicator with the ability to convey subtle or complex messages clearly, as appropriate for the topic and audience.
  • Quickly analyse, incorporate and apply new information and concepts.
  • Experience in supervising, or working in a team of engineers
  • Materials handling sector experience

 

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

 

Charlie Burgess 02081236574 Recruiter 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

Security Controls Consultant

Security Controls Consultant Reference: TPS067  
SALARY Negotiable LOCATION UK & Holland
JOB TYPE Contract (12 months) DATE POSTED 09/01/2019
INDUSTRY Industial Automation
 
DESCRIPTION
Client: Established leader in Industrial Control Systems security, providing organisations with the services and solutions they need to transform the way they procure, build, integrate and manage their critical infrastructures. Major cybersecurity player within the Industrial Automation and Control Systems (IACS) Internationally.

Job Title Industrial Control Systems Security Consultant with strong experience in critical infrastructure sectors (Power, Oil&Gas, Transportation, Water, Manufacturing etc.) and a variety of cybersecurity disciplines including.

Industrial Automation and Process Control – Enterprise, IT and OT cyber security – Industry regulations including IEC 62443, NIST and other industry standards and regulations – Smart Grids and Digital Oilfields.

Desired Skills & Experience

  • Proven experience in performing control systems risk assessments, and security awareness training for systems operators, owners and vendors
  • Expertise on developing industrial control systems security programs, and securing IACS network architecture
  • Experience with operational technologies such as Remote Terminal Units (RTUs), Programmable Logic Controllers (PLCs), Supervisory Control and Data Acquisition (SCADA) software, and Distributed Control Systems (DCS) – Hands-on penetration testing and vulnerability assessment (White/Black Box) for mission-critical systems during FAT or SAT activities
  • Understanding of IACS security lifecycle and safety case – Fundamental understanding of IT and OT network communication protocols (For example – TCP/IP, UDP, OPC, IEC 101/104, Modbus, IEC 61850, WirelessHART, ISA100 etc.)
  • Active participation in design concepts and implementation strategies for various SIS, PLC and DCS systems to guarantee practical implementation of security standards
  • Understanding of contemporary and legacy security technologies used within a particular domain, such as Firewalls, IDS/IPS, Diodes, SIEM
  • Strong knowledge of networking technology (e.g. routers, switches, firewalls)
  • Must have the ability to quickly master, simplify, and communicate the value proposition of complex subjects to clients
  • Comprehend the customer’s business environment and suggest fit for ICS/SCADA security solutions
  • Perform pre-sales activities (e.g. proposals, presales calls, RFP responses)

Degrees & Qualifications

Bachelor’s or Master’s degree in Computer Engineering, Electrical Engineering, Computer Science or a related technical field

Minimum of two years in industrial control systems security experience – Excellent consulting and communication skills

CISSP, OSCP, GICSP, CISM or CISA certification – Fluent in Dutch and English

Charlie Burgess 02081236574 Recruiter UK Automation

Senior Process Engineer

Senior Process Engineer    Reference: TPS034  
SALARY All inclusive Hourly rate   LOCATION Netherlands
JOB TYPE Contract (6 months)   DATE POSTED 17/01/2018
INDUSTRY Biological  
         
DESCRIPTION        
 

Purpose of function:

As Process Engineer you will work in the industrial automation team. Together with your team you will be responsible for the further automation of existing production lines and the setting up and production of new ones.  Our clients has been one of the market leaders in producing (polio) vaccines from living viruses for decades and is continuously working on tightening our existing production process. In this role you become an integral part of this improvement process. This by further automating existing as well as designing and validating new production plants. Our systems are developed and managed as much as possible internally and built by external parties. You are the key pillar between external suppliers and internal production and maintenance departments, in addition you actively contribute to the company ambition:

Tasks and responsibilities:

  • The development and implementation of new production automation systems by: analysis, defining possible improvements, preliminary research and drawing up requirements for programs
  • Inform, advise and evaluate supplier plans
  • Setting up and managing test environments; preparation and execution of test procedures
  • 2nd line management of existing process automation systems; support production and maintenance during planned and unscheduled maintenance and breakdowns. Trouble shooting where necessary to solve problems in a team or in consultation with suppliers

Profile

  • Demonstrable HBO + work and thinking level
  • Relevant experience in a comparable role. Preferably gained in the bio-technology, food or pharmaceutical industry
  • Substantive know how to organise processes in a Controlled Production Manufacturing environment.
  • Knowledge of control systems like PLC, PCS, DCS and SCADA. BBio uses Siemens S7, TIA Portal, PCS7 and Simatic Batch where possible.
  • Preferably knowledge of GMP and GaMP quality systems.
  • Good command (word and writing) of English.

 

       

CSV Consultant

CSV Consultant   Reference: TPS032  
SALARY Negotiable   LOCATION Netherlands
JOB TYPE Contract (12 months)   DATE POSTED 16/01/2018
INDUSTRY Pharmaceutical      
         
DESCRIPTION        
Validation Engineer IT

Purpose of the function:

The Validation Engineer IT is responsible for managing IT validations from start to finish (also often referred to as computerised system validation). For …………………. this concerns the validation of IT systems that are typical for pharmaceutical production companies, including ………………………………………. The so-called Process Control systems, such as SCADA systems that are used to control and monitor production lines, also belong to this category.

Main tasks and responsibilities:

Performing GMP impact assessments.
Ensure that the quality requirements from the regulations and …………… standards are translated correctly to the user requirements of a system. Consider requirements regarding Back-up & Restore, Incident Management, Disaster Recovery, Electronic Records and Electronic Signatures.
Determine and implement a validation approach for the system (including any interfaces).
Facilitating so-called Design Verification (or Design Qualification) sessions;
Managing the tests according to a structured and formally established procedure.
Assess and report the test results. Review deviations and corrective measures and coordinate possible re-tests.
Ensure that suppliers comply with Astellas standards for design, documentation and validation.

Professional profile:

Educational attainment
Minimum HBO level (or thinking level)
Knowledge of the formulation and packaging processes.
Preferably knowledge of Electronic Batch Records Systems, Laboratory Information Systems or systems that are comparable in terms of complexity and degree of integration.
Knowledge of GMP regulations (Eudralex Volume 4, 21 CFR Parts 210, 211 and 11) and ISPE Good Practice Guides (GAMP5).
Knowledge of ICT and Industrial Automation.
Knowledge of System Life Cycle methodologies.
Competences Planning and organizing.
Analytical skills.
Quality-oriented and accurate work.
Excellent communication skills in word and writing both in English and in Dutch.
Experience
Minimum 5 years experience in the pharmaceutical or medical device industry or laboratory.
Minimum 3 years experience with the validation of computer systems in the aforementioned industries.
Experience with the validation of an Electronic Batch Records Systems, Laboratory Information Systems or systems that are comparable in terms of complexity and degree of integration.
Experience with System Life Cycle methodologies.

Recruiting Consultant – Charlie Burgess – 0208 432 6080

 

 

 

       

Senior Control Engineer (Ireland)

Senior Control Engineer    Reference: TPS018  
SALARY Negotiable LOCATION Ireland
JOB TYPE Permanent DATE POSTED 17/08/2017
INDUSTRY Pharmaceutical
  PLC focused  Allen Bradley
DESCRIPTION HMI SCADA Wonderware
Established automation System Integrator in Ireland requires experienced Controls Engineers to engage on two separate projects in Ireland (Cork or Limerick). The position is focused in the healthcare/nutrition space and will require you will have a minimum of 5 years’ experience working with validated Automation systems in the pharmaceutical manufacturing environment.

The suitable candidate for this position will be responsible for;

  • Development and implementation of software solutions through change control as required while understanding impact of actions to Manufacturing and Facilities equipment.
  • Ability to program, diagnose and troubleshoot Allen Bradley Rockwell PLC and HMI application for automated process equipment.
  • Provide technical and automation operational support to Engineering, Manufacturing, Validation and Facilities departments.

My client requests that your profile shows a good level of long-term commitment on Permanent opportunities in previous careers. They offer high level of investment in their candidates i.e training courses, skill development.

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