Automation Engineer

Hobson Prior are looking for an Automation Engineer to join a leading biopharmaceutical organisation who are focused on developing and manufacturing first-class biosimilar medicines. This is a permanent position which will be based in Iceland.

Job Responsibilities:

• You will report directly into the Automation Team Leader.
• You will be accountable to work in accordance to the organisation's Engineering related policies and procedures.
• Working in a team with minimum supervision to support existing SME on site DeltaV DCS.
• Working with business owners to assimilate and generate Automation related URS.
• Following cGMP and ISPE GAMP5 guidelines.
• Facilitating change controls, CAPAs, Deviation Management and Risk Management associated with site DeltaV DCS.
• Generation, execution, review & approval of DCS Automation test protocols and associated qualification documents as required to support CAPAs and change controls.
• Interaction with and management of suppliers of DeltaV DCS / Finesse.
• Partaking in re-qualification of DCS Infrastructure with GMP impact associated with the DeltaV DCS when required.
• Supporting DeltaV Automation system throughout its life cycles including compliance with FDA 21CFR Part 11 and EudraLex Annex 11 Volume 4 and periodic reviews.
• Partaking in the review of current and future Automation procedures.
• Coordination with other departments or outside contractors/vendors to complete qualification associated with the Automation systems.

Key Skills:

• Excellent written and verbal communication skills.
• Fluent command of the English language, both written and verbal.
• Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel in addition to other computer skills.

Requirements:

• At least 10+ years of related experience including the configuration, implementation and/or maintenance of DeltaV DCS and associated IT Infrastructure Qualification.
• A strong understanding and practical application of ISPE GAMP 5 guidelines.
• You will need to require a minimum of a bachelor's in chemistry, Engineering, or Life Sciences.
• Knowledge of cGMP standards and experience in a GMP environment is required.
• Knowledge of and experience with FDA and/or EMA regulatory requirements in cGMP, 21 CFR Part 11 and/or EU GMP Annex 11 is required.
• Knowledge of and experience in Operational/IT Infrastructure application and qualification.

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.