Description
Validation Engineer (Clean Utilities)Our biopharmaceutical client is looking for an experienced validation engineer to support them with the set up of a new clean area, specifically to focus on the documentation preparation for the project.
Location: Germany
Duration: 6+ months
Tasks and Duties
• Collaborating with the validation team to assist with validation of the clean utilities systems including water and compressed air for a new clean area.
• Support the preparation for the new clean areas by:
o Writing a project validation master plan.
o Write and Revise validation procedures und Standard Operating Procedures (SOPs).
o Write validation plans and protocols for ongoing validation/re-validation of the new clean area.
• Partnering with vendors and maintenance and operations teams to establish standard operating protocols.
Requirements:
• Experience in pharmaceutical/biopharmaceutical manufacturing essential.
• Extensive familiarity with project work, delivering to tight deadlines required.
• Experience in the validation of utility systems such as water, compressed air, Clean Steam, Purified Water, WFI, Chilled Water systems, Cleanroom HVAC required.
• Prior experience of writing project documentation including project validation master plan, SOP, protocols and other project documentation required.
• Familiar with the operation of Cleanroom environments.
• Outstanding knowledge of GMP and FDA requirements essential.
• Good spoken and written English, German language skills advantageous.