Qualification Engineer

Qualification Engineer – Sterile Manufacturing

Location: Near Munich, Germany

Contract: 6 months

Working Model: On-site

Industry: Pharmaceutical / Sterile Manufacturing

We are currently supporting a leading pharmaceutical manufacturing organisation with an experienced Qualification Engineer role for an initial 6-month contract near Munich.

The role will be focused on the hands-on qualification of sterile manufacturing equipment , with particular emphasis on aseptic filling lines .

Key Responsibilities

• Take ownership of the full equipment qualification lifecycle , including: FAT, SAT, IQ, OQ
• Support qualification activities within a sterile / aseptic manufacturing environment
• Perform hands-on execution of qualification protocols on-site
• Author, review and execute qualification documentation
• Ensure qualification activities are completed in line with GMP requirements and site procedures
• Support investigation and resolution of qualification-related issues and deviations
• Work closely with Engineering, Manufacturing, Quality and Validation teams

We are looking for candidates with:

• Strong experience in equipment qualification within pharmaceutical manufacturing
• Previous experience working with aseptic filling lines / sterile manufacturing equipment
• Proven hands-on experience across FAT, SAT, IQ and OQ
• Strong technical documentation experience, including both protocol authoring and execution
• Good understanding of GMP-regulated pharmaceutical environments
• Ability to work independently and take ownership of qualification packages
• Previous experience working on-site within pharmaceutical capital projects, engineering or validation environments

Experience with additional sterile equipment such as isolators, vial filling systems, pre-filled syringe lines, washing machines or lyophilisers would be advantageous.

Contract Details

• Initial 6-month contract
• On-site near Munich
• Immediate / short-notice availability preferred

If you are an experienced Qualification Engineer with strong sterile manufacturing experience and would be interested in discussing the project, please apply or contact me directly.