5 days ago

Senior Manager Qualification

1094 CSL Behring Rec. Fac. AG

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Senior Manager Qualification

Senior Manager Qualification

CSL Behring is a leading global biotherapeutics company committed to its promise to save 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.

The CSL Behring Recombinant Facility (RCF) in Lengnau is part of CSL's ongoing global expansion strategy to support the company's long-term growth plans.

The new plant in Lengnau will manufacture three recombinant coagulation factors to treat hemophilia A & B patients. For one of these products we have already received marketing approval, for the second product we expect global market launch this year. The Lengnau site project generates an investment of several hundred millions USD and will create around 300 new jobs when it is fully operational in 2019/2020.

Are you interested in being part of this exciting project?

We are looking for an experienced

Senior Manager Qualification

This position requires an engineering and/or qualification background with relevant experience within the Life Sciences industry in facility, utilities and/or equipment qualification. The candidate should have good experience of all project phases, including design, procurement, construction, C&Q and operational readiness, where applicable. There is a strong desire for the successful candidate to transition into a long-term operational support role within the operating RCF facility (e.g. re-qualification lead).

Main Responsibilities and Accountabilities:

The main responsibilities for this position are:

  • The role will oversee the execution of qualification activities, working closely with the Engineering Services (ES), the Engineering Partners as well as Quality Team to deliver qualified facilities, utilities and equipment, ready for commercial production
  • The role is responsible for ensuring that qualification activities are executed in a manner that is compliant with regulatory expectations
  • The role involves GMP documentation of qualification activities
  • The role has active involvement in issue resolution, especially in cooperation with Quality Management counterparts

    Technical duties:

    Collaborate and oversee the activities described by the equipment commissioning, participate as ES representative to the elaboration and approval of the following documents:

  • Equipment URS or System URS
  • Equipment and System Risk Assessments (RA)
  • Equipment and System Requirements (RS) Specifications
  • Contributes as ES representative to FAT and SAT activities including review of FAT protocols and FAT reports as well as SAT protocols and reports
  • Ensures as ES representative that the Documentation principles according to the qualification requirements are an integrated part of all elements (URS, RA and RS) leading to qualification activities (DQ, IQ, OQ an PQ)
  • Prepares DQ, IQ, OQ and PQ documents
  • Elaborates, reviews and signs all URS, RA, RS, FAT, SAT, DQ, IQ, OQ an PQ documents representing ES QM, as appropriate
  • Provide diligent GMP oversight of and documentation approval for Qualification activities, ensuring performance is in line with the site's Core Values, Business Plan and the CSL Quality Management System
  • Provide feedback (i.e., recommended improvements) to the Lengnau Qualification system (i.e., policies, procedures, training, etc.)
  • Work collaboratively with all stakeholders (e.g., QA, QM, Engineering,  Production, R&D, QC staff and others) and the external Partners to ensure that qualification activities are planned and delivered in an efficient timeframe
  • Maintain knowledge relating to engineering qualification activities with an emphasis in risk-based, science-based approaches to Qualification and to current Good Engineering Practices

    General or administrative duties:

  • Executes documentation and archiving of the GMP relevant documents pertaining to this activity (URS, RA, RS, DQ, IQ, OQ, PQ documentation) according to the Engineering Quality Management System
  • Executes the handling of deviations and changes related to the activities in scope of this position. Reviews and assesses deviations and changes owned and executed by other partners
  • Ensures effective communication between stakeholders involved in commissioning and qualification activities. Informs supervisor periodically on ongoing activities and on issues related to the activities in scope of this position

Qualifications & Experience:

  • Degree (Bachelor or Master) in Engineering or Life Sciences 8Biology, Chemistry, etc.), Dipl. Ing. or M.Sc. or B.Sc. or equivalent
  • Qualification experience preferably gained on a Life Science / Pharma / Biotech Upstream/Downstream/Fill Finish manufacturing facility
  • Several years of successful commissioning and/or qualification experience on mid-sized and major projects with high complexity in the chemical, biotech or pharmaceutical industry
  • Proven experience and knowledge in chemical, biotech or pharmaceutical process, automation and engineering
  • Proven experience in cGMP, GLP & cGxP and qualification/validation
  • Language: Fluent German required, with proficiency in English beneficial (written and spoken)
  • Able to work well both independently and in a team environment to ensure successful outcomes
  • Excellent time management skills, with the flexibility to manage changing priorities and multiple tasks

Are you motivated to join us in this exciting journey to establish a state of the art pharma manufacturing facility with most advanced technologies?

Offices will be in Stöckacker, Bern, and later in Lengnau.

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. For initial information you are welcome to contact Recruitment at +41 31 344 12 51.

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