
Senior Project Engineer
3 weeks ago
Overview
PE Global is recruiting for a Senior Process Engineer for a 12 month contract, with a leading multi-national Pharma client based in Dublin.
This is an initial 12-month contract position, with a view to extend.
This role will require the candidate to support manufacturing at various aseptic drug product contract manufacturing sites around Europe.
Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production.
Depending on assignments, the candidate may support a broad range of product formats (cartridges, syringes, freeze dried and liquid vials) and a broad range of product types (including monoclonal antibodies, therapeutic proteins, small molecules and more novel modalities), across multiple manufacturing sites.
International travel will be required to visit contract manufacturing partner sites in Europe.
Please note our client cannot assist with visa sponsorship and candidates must have the correct visa to live and work in Ireland.
Responsibilities
Develop as a drug product technical expert, to provide leadership and solutions troubleshooting parenteral drug product manufacturing, for all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices for parenteral products through the new product introduction (NPI) or commercial phases.
Work with contract manufacturing partner SME's, Global Operations, Contract Manufacturing Quality and drug product process teams.
Work as a member of cross site teams to support contract manufacturers and to identify and resolve potential issues
Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing, process characterisation, technology transfer, and process validation.
Troubleshoot issues with drug product processing technologies and equipment.
Identify and implement operational improvements for current and new sterile operations.
Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
Visit contract manufacturing sites to observe production operations and build relationships
Education/Experience
3 -5 years' pharmaceutical manufacturing experience in either a drug product or drug substance manufacturing environment
Knowledge of cGMP's
Proven problem-solving ability
Excellent oral and written communications skills
Strong academic results in a third level bachelor's degree in Science, Engineering or a relevant quality discipline
Full clean driving licence required to facilitate travel
Preferred Qualifications and Experience
Language skills such as Italian or German.
Masters or PhD in a Science or Engineering or related discipline
Experience with aseptic drug product processes such as; component preparation (siliconization, autoclaving, depyrogenation), sterile filtration, filter integrity testing, filling, freeze drying, capping, manual and automated visual inspection
Experience with different aseptic drug product presentations such as pre-filled syringes, cartridges, lyophilised vials and liquid vials
Experience with the quality testing methods and interpretation of results for biological molecules
Aseptic drug product validation experience such as; media fill, sterilisation validation, equipment qualification, process validation
Experience dealing with contract manufacturing organisations
Demonstrated ability to lead and take responsibility
How to apply
Interested candidates should submit an updated CV.
Please click the link below to apply, call Chloe on or alternatively send an up to date CV to
Contact:
Chloe Slingsby, PE Global
Job details
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Project Management and Manufacturing
Industries: Pharmaceutical Manufacturing
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