Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE
GXP CONSULTING Switzerland
is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry's expertise and support to our clients in the complete range of product life cycle.
Senior Quality Engineer (m/f/d)
To support our client and ensure consistently high levels of quality and compliance, we are looking for an experienced
Senior Quality Engineer
. In this role, you will take on a key responsibility for qualification, validation, and quality assurance activities within a cGMP-regulated environment and actively contribute to the continuous improvement of processes, systems, and teams.
Key Responsibilities:
* Take responsibility for the planning, coordination, and execution of
qualification and validation activities
for equipment, systems, utilities, cleanrooms, and
cleaning processes
across the entire lifecycle
* Ensure the
ongoing GMP-compliant status
of existing systems, including planning and oversight of
re-qualification and re-validation activities
* Prepare, review, approve, and execute qualification and validation documentation such as
DQ, IQ, OQ, PQ
, as well as overarching validation strategies
* Participate in
change control, deviation, and CAPA processes
related to qualification and validation activities
* Analyze existing processes,
identify optimization opportunities
, and actively support the implementation of improvement measures
* Support the
preparation, execution, and follow-up of regulatory inspections
(e.g., FDA, EMA) as well as internal and external audits
* Prepare, review, and maintain additional
GMP-relevant documentation
(e.g., SOPs, risk assessments, logbooks)
* Actively contribute to cross-functional and project teams, serving as a
key interface
between Engineering, Manufacturing, QA, and external partners
* Provide
technical guidance and mentoring
to junior colleagues in validation and quality system activities
* Ensure proper documentation within
electronic quality management systems
(e.g., SAP, MasterControl, or comparable systems)
* Actively promote a strong
quality, safety, and compliance culture
across operations
Qualifications:
* Bachelor's or Master's degree in
engineering, chemistry, pharmacy, process engineering
, or a comparable scientific or technical discipline
* At least
5 years of professional experience
in a
cGMP-regulated environment
(pharmaceutical, biotech, or medical device industries)
* Several years of hands-on experience in
Quality Assurance
, with a strong focus on
commissioning, qualification, and validation
* Very good knowledge of
GMP requirements
and international regulatory standards (Switzerland, EU, USA; FDA, EU GMP, ICH)
* Specific experience in cleaning validation and/or Computer System Validation (CSV)
is a strong advantage
* Experience in managing deviations,
root cause analysis
, and continuous improvement initiatives
* Structured, reliable, and precise working style with a high level of autonomy and accountability
* Solution-oriented, resilient, and communicative personality with a strong quality and customer-focused mindset
* Fluent in German and English
, both written and spoken (German required; English at C1 level or higher)