Director of Engineering (remote-based)

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Hobson Prior is working with a leading pharmaceutical organisation who are seeking a Director of Engineering to join their team on a permanent basis and have the ability to work remotely.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Generates and executes life cycle documentation for cleaning, shipping, facilities, utilities, systems, equipment and processes for qualification/verification.
• Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
• Writes reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
• Writes procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments.
• Performs P&ID Walkdowns. Performs Thermal mapping of temperature controlled chambers, warehouses, and SIP processes.
• Supports the resolution of regulatory observations or manufacturing site.

Requirements:

• Bachelors Degree in engineering, science, or similar field.
• 2-5 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry.
• Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation.
• Experience with temperature mapping.
• Working knowledge of FDA and cGMP regulations and documentation practices.
• Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.