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

Principle Automation Engineer

Principle Automation Engineer Reference: TPS066
SALARY €55/h – €65/h LOCATION Dublin, Ireland
JOB TYPE Contract (12 months) DATE POSTED 09/01/2019
INDUSTRY BioPharma
DESCRIPTION
Client; BioPharma corporation

Job Title: Principle Automation Engineer

Requirement;

To satisfy sustained and increasing demands in the Engineering & Automation Department, this client is now looking to recruit an experienced Principle level Automation Engineer with the dynamism and motivation to become an expert member of our team. The position will be based in their Dublin office and will require work at customer sites nationally or internationally.

You will be reporting to the Automation Engineering Manager, your primary role will be to specify, design, configure and program Industrial Automation Systems for integration into plant, machinery and equipment for our customers.

Responsibilities

  • You will develop the concepts for new automation and machinery or the upgrade and refurbishment of existing assets.
  • You will design and program PLC based systems and HMIs.
  • These systems will be effectively integrated with other plant or machine elements including, Robotics, PLC based control systems, Motion Control Systems, Hydraulic and Pneumatic systems, Machine and Process Safeguarding elements etc.
  • As Safe Automation is one of our core businesses you will design the safety related control system part of the automation and machinery solutions for our customers.
  • You will prepare systems at the Pilz facilities for acceptance testing and qualification.
  • You will manage the installation and commissioning of automation equipment the systems at customer
  • You will provide the necessary documentation to our customers for operation, maintenance and qualification of our systems.

Essential Experience/Knowledge:

  • Degree in engineering, preferably electrical, control or instrumentation systems.
  • 3+ years’ experience in the design and programming of automation systems. Such experience must include:
  • Commissioning, troubleshooting and programming; and the contribution to Electrical and Mechanical installation and commissioning teams.
  • Generation of electrical drawings, cable schedules and termination diagrams
  • PLC Control System programming and configuration
  • Desirable Experience
  • Experience in the pharmaceutical/bio-pharma
  • Experience in process control system design
  • HAZOP
Charlie Burgess Recruiter 02081236574 UK Agency Automation

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).