My client is a fast-growing biopharmaceuticals company based in the South-West of England.
Experts in developmental production and the bringing to market of biologicals, my client have decades of experience in production, characterisation, process and analytical validation of life saving biopharmaceuticals, including the Anthrax Vaccine.
Taking on the mantle of Process Engineer will see you as the System technical expert for all Engineering Utilities systems within the GMP Envelope. You will be responsible for identification of and managing small projects/initiatives relating to utilities systems and interfacing with the wider Engineering group to ensure Utilities systems within the GMP envelope remain compliant with current Good Manufacturing Practice.
Additionally, the Process Engineer may work within an Integrated Process Team to provide operational support to the manufacture of biopharmaceutical products.
You will become the Subject Matter Expert for all Critical Utilities (e.g. WFI, Clean Steam, and Purified Water) systems within the Pharmaceutical Production Envelope.
As such you will interface with key stakeholders including equipment users, capital project managers, and the site principal maintenance contractor, to ensure these critical systems remain in compliance with best industry and regulatory practice. As a core member of an Integrated Process Team you will provide operational engineering support to the manufacture of biopharmaceutical products alongside other core members from the Production and Quality functions. You will have delegated responsibility from the Director of Engineering to design, manage and deliver process improvement projects and represent the group in the delivery of major facility expansion/refurbishment projects.
Responsibilities may include: -
Design and implementation of Process Engineering improvement projects
Main point of contact for Engineering issues for the Fermentation Process Plant.
Responsible for troubleshooting and liaising with maintenance technicians, engineers and users to establish the root cause, develop and manage appropriate corrective action plans and for failures - performance issues relating to the Utilities systems and process equipment (i.e. fermenters, centrifuges, CIP systems, autoclaves, HVAC, effluent systems).
Planning and execution of site shutdowns.
Supervision of Junior Chemical Engineers
Attending and representing the company in FATs, SATs and commissioning for Utility Systems and Process Equipment.
Provide engineering support to Capital Project teams (i.e. design reviews, HAZOPs).
Writing, and reviewing User Requirement specifications for new equipment, SOPs, and generation of design documentation related to Utilities systems and process equipment within the GMP envelope.
Responsible for owning Non-Conformances, CAPAs, Change Controls and Risk Assessments.
Involved in FDA and MHRA Regulatory inspections.
Are you ready to take on new responsibilities and begin the next chapter of your career?
Salary is negotiable on experience
For more information and a confidential discussion, please contact Kieran Whittaker on the below: -
Tel: 0161 923 8174