CQV Technical Lead with Fill Finish Experience

**Key Responsibilities**: - Lead and execute CQV activities for Fill Finish equipment and processes. - Develop and review validation protocols (IQ, OQ, PQ) and reports. - Coordinate with cross-functional teams to ensure timely completion of CQV deliverables. - Troubleshoot and resolve technical issues related to Fill Finish processes. - Ensure adherence to...

For a project at our client’s site, based in **Stein (AG)**, we are looking for an experienced Quality Assurance Manager C&Q - Aseptic Fill-Finish Facility (w/m/d) In this role, we are looking for someone who will be responsible for the Commissioning & Qualification (C&Q) compliance of an aseptic fill-finish drug product manufacturing facility CAPEX...

Job description: Responsibilities: As part of the C&Q team reporting to the C&Q Manager, the main responsibilities and tasks include but are not limited to: Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans. Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering,...

Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

Responsibilities:Coordinate and track the technical specification and standards creation and updates associated with the targeted areas for improvement, including guidance documents, procedures, and policy where necessary.Collaborate with internal SMEs and standard owners to progress the technical specification and standard review, ensuring alignment with...

For one of our clients based in Stein (Aargau), we are currently looking for a QA Specialist that would be responsible for the qualification and validation compliance of equipment and computerized systems. Ideally someone who has experience in a QA role for the CSV / Automation of GMP systems related to aseptic fill-finish processes and facility.Key...

Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

Switzerland, Stein**Student Internship in Pharmaceutical Manufacturing for 6 - 12 months**: Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help...

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

Responsibilities:Acting as subject matter expert (SME) on following Lonza CQV / CSV standardsCSV person of contact of the assigned system till the handover to the operation organizationParticipate to the system impact assessment as CSV SMEDefine with EMR and Package Units vendor the most appropriate design for vertical integration in the Lonza...

Switzerland, SteinCleaning Validation Expert Location - Stein, Switzerland Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In...

**Beschreibung** - support drug product formulation development and manufacturing activities at internal or external manufacturing sites for assigned projects in line with the project plan, guidelines and procedures -collaborate with operational colleagues working on your process at the respective manufacturing sites -take accountability for formulation and...

D-ploy is an IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA.We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT...

We are seeking a QA Specialist, CSV & Automation.The ideal candidate will be responsible for overseeing the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, utilities, and GMP manufacturing as part of Lonza's CAPEX project portfolio in Stein, AG.Key Responsibilities:Oversee the qualification and...

Job description: - The scope of activities includes the coordination on the installation of equipment, HVAC & Utilities (20%) - Drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements. - Validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution,...

**Beschreibung** Reports to: CAPEX Lead ADC Dolphin / Technical Project Manager -Support and Review of Design Documents related to their Discipline -Leads and Coordinates Sensor Risk Assessment according Project Standards -Ensures Swiss and Project Standards are kept. -Coordination of Operations SMEs, Global SMEs and Design Team -Oversee Deliverables in...

ResponsibilitiesAssists in the development of the turnover process including roles and responsibilities, workflows and interfacesSupports in the coordination of the turnover scope with Engineering, Construction and CQVPreparation and support of system boundaries for process and non-process systemsManagement and direction of Mechanical Completions Walkdowns,...

**Beschreibung** Reports to: CAPEX Lead ADC Dolphin / Technical Project Manager -Support and Review of Design Documents related to Building Services and Utilities -Ensures Swiss and Project Standards are kept. -Coordination of Operations SMEs, Global SMEs and Design Team -Oversee Deliverables in their Discipline to support and ensure timely completion of...

Job description: The scope of activities includes the coordination on the installation of equipment, HVAC & Utilities (20%) Drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according to cGMP requirements. Validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution,...