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.