QC Analytics Expert (80–100%)

Job Brief

ATP-CGPharm has been supporting clients in the Life Science Industry for more than 30 years, delivering expertise in facility and process engineering, commissioning, qualification & validation, quality assurance and quality control consulting, environmental monitoring and GxP Digital Solutions.

As a QC Analytics Expert, you will play a key role in new facility and major expansion projects within GMP-regulated pharmaceutical and biotechnology environments. You will support clients from early concept phase through commissioning and operational readiness of new Quality Control laboratories. Acting as the subject matter expert for analytical QC, you will bridge engineering, validation and laboratory operations.

Responsibilities

• Supporting the conceptual design of new QC laboratories (greenfield and brownfield projects)

• Defining laboratory layouts, material and personnel flows, zoning concepts and compliance requirements

• Developing User Requirement Specifications (URS) for analytical laboratory equipment and QC infrastructure

• Supporting equipment selection and technical evaluation (e.g. HPLC, GC, dissolution systems, spectroscopy, stability chambers, balances, sample preparation systems, etc.)

• Aligning laboratory concepts with GMP, data integrity and regulatory expectations

• Supporting FAT/SAT, commissioning and qualification (IQ/OQ/PQ) of analytical equipment

• Ensuring readiness for GMP inspections prior to go-live

• Writing and reviewing GMP documentation including SOPs, laboratory concepts, validation documentation and risk assessments

• Supporting method transfers and implementation of analytical procedures in newly established labs

• Acting as interface between engineering, CQV, QA and future laboratory operations teams

• Contributing to project timelines, technical reviews and operational start-up planning

Requirements

• University degree in Chemistry, Pharmaceutical Sciences, Analytical Sciences or a related discipline

• Several years of hands-on experience in GMP-regulated QC analytical laboratories (pharma or biotech)

• Proven experience in new facility projects, laboratory setup, lab relocation or major lab expansions

• Strong practical expertise with common analytical techniques (e.g. HPLC, GC, UV/VIS, IR, dissolution, titration, etc.)

• Experience in writing URS and supporting equipment qualification (IQ/OQ/PQ)

• Sound knowledge of GMP regulations, EU GMP Annex 1 (where relevant), FDA requirements and data integrity principles

• Experience in drafting SOPs and establishing QC documentation systems

• Structured, proactive and solution-oriented working style

• Strong communication skills and ability to work in interdisciplinary engineering and project teams

• Willingness to travel within the German-speaking region of Switzerland

• Fluent in German and English

Our Offer

ATP-CGPharm offers long-term career opportunities within a stable and growing organization operating at the forefront of Life Science engineering and compliance.

In addition to an inspiring and collaborative work environment, we offer:

• Attractive remuneration packages

• Excellent social security coverage

• Professional development and continuous training

• Diverse and challenging projects with leading Life Science companies

• A culture that values expertise, commitment and personal growth

Start date: Immediately
Additional Requirements:

• No visa sponsorship required

• Must be authorized to work in Switzerland