Engineering , Science, Pharmaceutical & Food

Manufacturing Operations – Vial and Syringe

  • Contract
  • Remote
  • Dublin South
  • 41936923

PE Global is currently recruiting for a Manufacturing Operations Role for a leading multi-national Biotech client based in Dun Laoghaire.

This is an initial 12-month contract shift position.

 

ROLE:

  • Function as the site interface between the Product Delivery Teams and Manufacturing operations.
  • Develop, review and approve generic batch records and parameter value lists across Formulation, Filling and Inspection
  • Develop, review and update Production, Engineering, Operating Procedures & training materials
  • Assist in providing training on scientific or technical aspects of the process/project
  • Evaluate, plan, and implement solutions for process improvement opportunities
  • Support scheduling and execution of Characterisation, Engineering and PPQ runs including ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data
  • Provide troubleshooting support throughout the project and on the floor during execution of activities
  • Hold people to account for delivery and behaviours within Product team
  • Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing
  • Partner with Learning & Performance to define training strategy’s for NPI’s and complex projects
  • Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences
  • Develop, review and update Protocols for manufacturing activities
  • Documentation and approval of protocol deviations for manufacturing activities
  • Liaise with Process Development regarding process changes in an effective and timely manner
  • Own and lead change controls as required by the NPI Project Team
  • Review and approve bills of materials
  • Develop, review and update Product Quality Risk Assessments
  • Contribute and assist with corporate, FDA, HPRA and other regulatory bodies during company audits

 

REQUIREMENTS:

  • Bachelor’s degree in a science discipline.
  • Knowledge of relevant regulations and regulatory requirements (GMP, EH&S)
  • 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
  • Project Management and organizational skills, including ability to follow assignments through to completion
  • Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity
  • Negotiation and Influence skills
  • Take initiative to identify and drive improvements
  • Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) and good Presentation skills
  • Escalate issues professionally and in a timely manner
  • Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area
  • Ensures compliance within regulatory environment
  • Demonstrated ability to work independently and deliver right first-time results under minimal direction

 

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@peglobal.net 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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