Lead Engineering Services Quality Management (ESQM) Engineer

CSL Behring Lengnau AG (Lengnau BE, Schweiz) Vor 6 Tagen veröffentlicht

With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat people with life-threatening medical conditions and to help them live full lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.

In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies. In May 2020, CSL announced the strategic partnership with Thermo Fisher Scientific, the world leader in serving science. Thermo Fisher will lease and operate the Lengnau state-of-the-art biotech manufacturing facility once construction is completed in 2021. It is anticipated that employees at the site who are engaged for the operation of the site and the commercial production of our therapies in Lengnau will automatically transfer to Thermo Fisher Scientific once construction is complete.  Today, more than 200 employees work in Lengnau.

You can find more information on the strategic partnership with Thermo Fisher here and some more information about the prospects of a future career with Thermo Fisher here.

We are looking for talented and dedicated personalities that share our passion to develop and deliver innovative therapies. With your commitment, reliability and high-quality standards you help us to improve the quality of life for those in need.

We are currently recruiting for a

Lead Engineering Services Quality Management (ESQM) Engineer

The lead ESQM engineer is responsible for maintaining the quality framework during the engineering phase of the project.

Main responsibilities:

  • Ensure quality is engineered into the project by the design engineering team.
  • Ensure project quality is delivered by construction management, contractors, vendors and commissioning engineers.
  • Implementation of Project Quality Management plans, audit processes, schedules and document review process to ensure the use of Good Engineering Practice and Good Documentation Practice.
  • Collaboration with project teams to deliver project quality.
  • Identify areas of concern and report quality and compliance issues to the Head of ESQM.
  • Perform Vendor Turnover Pack (VTOP), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Construction Turnover Pack (CTOP), System Mechanical Completion and Pre-commissioning Dossier (SMCPD) and Room Mechanical Completion Dossier (RMCD) reviews, Installation and Operational Commissioning (IOC) protocol review & approval pre and post execution and QA final reports.
  • Develop and maintain the Audit Program, undertake quality audits as scheduled conducting internal audits and audits of key contractors
  • Review project documentation, procedures and deliverables for compliance with applicable CSL and international standards.
  • Approve project documentation on behalf of ESQM.
  • Provide Facility Project quality training including Good Engineering Practice (GEP) and Good Manufacturing Practice (GMP) awareness training.

Key Interfaces:

  • ESQM Team Members
  • Project Leadership Team
  • CSL Design Team
  • Commissioning, Verification & Qualification Team
  • CSL Construction Management
  • QM-VAL
  • Plant Engineering Services

Qualifications:

  • Degree in Engineering or Science preferable
  • Strong operational experience gained in construction, commissioning and qualification environment preferably in Life Science/Pharma/Biotech/Fill Finish facility
  • Proven experience and knowledge in process, automation and engineering relating to pharmaceutical of Biotech facilities
  • Proven experience in GxP (GMP, GEP, GDP), qualification and validation
  • Organizational skills with the ability to handle multiple assignments
  • Strong communications skills

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.

Worker Type:

Employee

Worker Sub Type:

Regular

Lead Engineering Services Quality Management (ESQM) Engineer

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