In early 2022 Unispace acquired BioPharma Engineering (BPE) to further develop its passion to support the Life Sciences industry with market-leading design engineering, project management, and workplace/lab consultancy. At Unispace Life Sciences they are focused on engaging the most talented and passionate professionals who believe that everyone should work in an environment that inspires productivity, peak performance, and delivers wellbeing. Across their 50+ global studios, they have a positive work environment that fosters open, collaborative, and supportive cultures populated by highly independent and motivated people. As one of the leading engineering design and project management firms in the industry, Unispace offers a full complement of services including strategy development, design, and construction of laboratories and workplaces focused on Life Sciences.
BioPharma Engineering is delighted to be recruiting for a global-pharmaceutical company who are implementing a large project in Dublin. The Lead Chemical API Process Engineer is a key part of client team who will be responsible for steering and delivering this key Chemical API project consisting of both batch and continuous manufacturing processes
Reports to Project Technical Manager and coordinates with site cross functional team supporting the capital project including site process SME's, Operations lead, Validation, QA, Facilities Maintenance and Metrology.
Technical governance throughout the project lifecycle.
Lead a collaboration with site cross functional team and engineering firm to design and specify critical technical packages including P&ID's, URS's and design qualifications to meet business requirements.
Support process risk assessments (HAZOP-LOPA, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements.
Support procurement's strategic supplier management efforts, establish qualified suppliers and bid evaluations.
Working with technology leading equipment suppliers, Design Engineering and Construction firms to successfully deliver state of the art integrated API manufacturing operations.
Providing construction phase technical audits and lead GMP equipment testing and FAT's including authorisation to release equipment from supplier to the site.
Providing technical support to equipment commissioning and validation.
Coordinate critical technical documents reviews and approvals from engineering firm or equipment supplier with site cross functional team and process SME's.
Educated to degree level in Chemical Engineering with experience in Chemical API operations
In-depth knowledge of API equipment including reactors and Nutsche type vacuum filter dryers.
Ability to work in a cross functional team environment with both internal and external collaborators.
Experienced in the start up and commissioning of API equipment in a licensed GMP commercial plant.
Experience with capital project delivery from business case development through project execution and current GMP regulations is highly beneficial
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