Aseptic Process Engineer

Proclinical are recruiting for an Aseptic Process Engineer to join a pharmaceutical organisation. This role is on a permanent basis and is located in Stein.

Responsibilities:

• Constantly record and preserve data of functional locations, equipment and spare parts, spare part lists, instruction manuals and SOPs, etc.
• Uphold history and records in SAP and actual status of plant PIDs.
• Assist with risk analysis and form SOPs and work instructions for the new facility and equipment within the area of accountability.
• Guarantee deviation and change management across the entire area of accountability.
• Serve as a representative for the facility throughout inspections and audits as an SME for area of accountability.
• Contribute to FATs, construction walkdowns, C&Q to allow a smooth hand-over of process equipment's.
• After the handover, you will guarantee the operation and the precise implementation of all maintenance actions of the process equipment in compliance with safety and cGMP needs.
• The ideal candidate will carry out all actions to uphold complete and updated system documentation.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to a degree level in an engineering or equivalent field in economics with a technical focus such as HF, FH, Dipl. Ing. / M. Sc. / B. Sc.
• Comprehension of aseptic production/manufacturing.
• Familiarity working within engineering and operations in a pharma organisation.
• Expertise in SAP-PM and computer literacy.
• Know-how of GMP compliance needs.
• Fluency in both German and English.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at +44 203 0590923.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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