SimoTech Support Highfield U12 all the way to Germany

SimoTech recently sponsored Highfield Under 12’s rugby team and their coaches, one of whom is our very own Kevin Nolan (CSV and Compliance Manager), to travel to Germany to play a number of games against rugby clubs based in the Cologne area marking the end of ‘mini rugby’ for these players, many of whom started playing rugby with Highfield at the age of 5.

For Highfield U12, goodwill over the years has made this long standing annual ...

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Engineer CQV (Sterilisation Validation)

Experienced CQV Engineer required for Bio-Pharmaceutical project in Leinster. Candidates should have previous Biotechnology or Life Sciences manufacturing experience. The ideal candidate will have experience of Autoclave CQV and Temperature Mapping.

The CQV Engineer will be responsible for ensuring that the Sterilisation Validation Activities associated with Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.

Major Responsibilities

  • Ensure all aspects of Sterilisation Validation adhere to required policies and procedures, including safety and training.
  • Autoclave load ...
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Automation Engineer Senior

We are looking for an experienced Automation Engineer for a Senior role for a project in Dublin. Candidates must have at least 5 years experience implementing and supporting automation systems for manufacturing organizations in the life sciences sector.

Background

  • Candidates should demonstrate technical, project and interpersonal skills, including but not limited to the following:
    • client interfacing and resolution of client concerns
    • solution definition
    • proactive support and resolution of issues
    • technical guidance from concept to delivery
    • system delivery, commissioning and validation.
  • Must be able to work independently with limited ...
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Equipment Engineer (Junior)

We require an Equipment Engineer for a pharmaceutical project in Dublin. Candidates should ideally have engineering experience in an asceptic pharmaceutical environment.

Overview

The role is responsible for support of all equipment and projects associated with vial washing/filling and capping.

Responsibilities

  • Continuous improvement programs for equipment reliability and availability (up to and including DiD).
  • Works in collaboration with the System and Line owner to execute documentaiton and other updates related to CAPA’s and change controls.
  • Monitors equipment performance and develop and maintain metrics in relation to ...
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Commissioning and Qualification (C & Q) Engineer

We require a Commissioning & Qualification Engineer for a project in Munster. Candidates must have at least 3 years qualification and validation experience in pharma/life sciences. Thorough understanding of cGMP and Quality procedures and guidelines and their implementation is essential.

Responsibilities

  • To assure cGMP compliance before, during and after validation/qualification activities
  • To assure that process systems (including automated process control systems), equipment, utilities and facilities are qualified/validated according to their intended use, product requirements, company procedures and regulatory guidelines.
  • To promote the importance of ...
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Tech Transfer Lead Senior

We require an experienced tech transfer / new product introduction lead for a pharmaceutical project in Leinster. Candidates must have senior/lead experience in cGMP manufacturing and be familiar with all aspects of the product manufacturing process.

Key Responsibilities

  • Lead the transfer of manufacturing site for a parenteral product throughout the tech transfer lifecycle from planning, development testing, process performance qualification through to regulatory submission.
  • Review and write tech transfer protocols and assessments, support manufacturing execution of test and qualification runs.
  • For their assigned product ...
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Tech Transfer Lead Intermediate

We require an experienced tech transfer / new product introduction lead for a pharmaceutical project in Leinster. Candidates must have senior/lead experience in cGMP manufacturing and be familiar with all aspects of the product manufacturing process.

Key Responsibilities

  • Accountable for success of the transfer project from project initiation to transfer, through regulatory approval.
  • Execute processes on site, per the required technology, characterization, and drug product specific knowledge that will be transferred to the facility.
  • Ensure that specifications are based on quality, cost and time ...
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Senior Process Automation Engineer

SimoTech requires experienced Process Automation Engineers for a pharmaceutical project in the midlands. Candidates must have 3- 5 years experience in the pharmaceutical/life sciences industry as well as previous project engineering, and have good vendor management, retro fit, new equipment install, and new product introduction experience.

Key Responsibilities:

  • Provide technical leadership and support for control systems to engineering, maintenance and process engineers across Manufacturing and Process Development as required. Supports the Process Automation Admin role as required for business impacting issues.
  • Proactively ...
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Automation Project Engineer

SimoTech requires an experienced Project Engineer for a pharmaceutical project in the midlands.

Candidates must have 3- 5 years experience in the pharmaceutical/life sciences industry and have automation, filling line and new product introduction experience.

Key Responsibilities:

  • Project engineer for Engineering Group providing technical support across, engineering, automation, filling line and new product introduction as required.
  • Liaise and communicate with site users and vendors to ensure control systems operate to maximum effect, and as per the Site IT Automation Strategy.
  • Record and investigate issues, ...
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Process Validation Engineer Senior

SimoTech requires a Senior Process Validation Engineer for a pharmaceutical project in Leinster. Candidates must be familiar with process validation and asceptic process simulations at sterile manufacturing sites and have 5 – 10 years experience in similar roles.

Major Responsibilities

  • Development of Validation Plans, Process Qualifications (PQs), and Process Simulations (Media Fills) for Vial / Syringe Filling.
  • Working with the team to ensure all aspects of activity within the Process development and Validation group adhere to required policies and procedures, including safety and ...
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