Sterile Manufacturing Engineering Expert

K-Recruiting GmbH; Osterreich; On-site; PEN 346,000 - 461,000; Full time

Job summary

K-Recruiting GmbH in Austria seeks a Senior Sterile Manufacturing / Engineering Expert with Annex 1 experience to assess equipment, analyze current vs target state, and design cost-efficient upgrades. The role focuses on upgrading existing lines without replacement, with strong on-site presence and qualification/validation exposure.

Start asap, 6 months plus, 1.0 FTE. Candidate should have extensive experience in sterile manufacturing projects and a pragmatic approach to retrofit solutions,

Qualifications

• Experience in sterile manufacturing engineering.
• Familiarity with Annex 1 standards and audits.
• Experience with qualification and validation activities is a plus.

Responsibilities

• Assess existing sterile manufacturing equipment.
• Perform current vs target state analysis and Annex 1 gap assessment.
• Develop pragmatic and cost-efficient upgrade/retrofit solutions.
• Avoid replacement of existing lines; focus on upgrading equipment.
• Strong onsite presence initially, ideally full-time.

Skills

Sterile manufacturing

Engineering

Annex 1 experience

Qualification & Validation

Job description

We are looking for a Senior Sterile Manufacturing / Engineering Expert with Annex 1 experience:

• Assessment of existing sterile manufacturing equipment

• Current vs. target state analysis and Annex 1 gap assessment

• Development of pragmatic and cost-efficient upgrade / retrofit solutions

• No replacement of existing lines, focus on upgrading existing equipment

• Ideally experience in Qualification & Validation

• Strong onsite presence initially, ideally full-time

• German language preferred

Start: asap

Location: Austria

Duration: 6 months +

FTE: 1.0