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.

 

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

 

Charlie Burgess +442081236574 UK & Ireland Agent  

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

 

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