Compliance Engineer - German Speaking

Compliance Engineer For my client, a leading international life?science company, I am looking for a Compliance Engineer (m/f/d) for a long?term project in Schaffhausen. Start: 07 April 2026 End: 31 December 2026, with possible extension Location: Schaffhausen, Switzerland - at least 3 days on-site GET GMP Support (m/f/d) with focus on: COMET / Risk Assessment We are seeking support from individuals with strong compliance awareness and technical know?how in the areas of pharma, parenterals, packaging, optical inspection, utilities and API/solids. The main task XXXX XXXX provide operational support to engineering teams within the COMET Quality System (NCs and CoCs), as well as to create and coach risk assessments - without taking over the subject?matter responsibility of the record owners in the first step. Main Tasks / Responsibilities

• Operational support and maintenance of COMET records (NCs and CoCs): entering, verifying, and completing all records in collaboration with the technical record owners.
• Supporting engineers: preparing and structuring all technical inputs so engineers can focus on their subject?matter contribution.
• Ensuring the quality and compliance of all risk assessments according to internal standards, methodologies, and GMP requirements.
• Coaching and moderating risk assessment meetings: preparing meetings, active moderation/coaching during sessions, structured follow?up, and deriving clear action items.
• Tracking and follow?up: monitoring due dates, tracking open actions, and proactively reminding responsible persons of deadlines and timely completion.
• Close collaboration with QA: strong connection to QA/QAE teams and escalation in case of deviations or risks.
• Managing multiple topics simultaneously: prioritisation, status reporting, and maintaining to?do and action lists.
• Supporting audits and inspections by providing and explaining COMET records and risk assessments.
• Subject-matter responsibility remains with the record owners; the role is supportive/operational and ensures quality compliance.

Specific Activities

• Support with entering, reviewing, and closing NCs and CoC records in COMET
• Preparing risk assessment workshops (agenda, inputs, moderation materials)
• Coaching participants on methodology, scoring logic, and documentation requirements during meetings
• Regular reporting to GET management on open actions, risk ratings, and deadline status
• Training and coaching colleagues on COMET usage and risk assessment best practices

Qualifications

• Completed degree in engineering or life sciences, or equivalent technical training
• Strong understanding of pharmaceutical processes - ideally experience with parenterals, packaging/optical inspection, UTIL and/or API/solids
• Proven experience in GMP environments
• Experience with quality systems/electronic QMS (COMET or comparable) strongly preferred
• Experience with risk assessment methods (e.g., FMEA, HAZOP or similar) advantageous
• Strong compliance mindset and experience enforcing standards
• Experience collaborating with QA teams; strong communication and facilitation skills
• Ability to manage several topics in parallel and consistently enforce deadlines
• Languages: fluent German, business?fluent English
• Nice to have: practical experience in a similar pharmaceutical environment

Personal Skills

• Proactive, service?oriented attitude - a "getting things done" mentality
• Confident when moderating and coaching in meetings
• Team player with a coaching mindset toward engineers
• Diligence, responsibility, and discretion
• Strong organisational skills, attention to detail, and reliability

If you are interested in this position contact me as soon as possible! Send your CV over our home page to Fabiola Miranda or per mail directly to f.miranda(at)realstaffing.com *Please note that since the position is in Switzerland, we are only able to work with people who have a European passport or already have a Swiss working permit/citizenship. SThree_Germany is acting as an Employment Business in relation to this vacancy.