Senior Validation Specialist - Computer Systems Validation (CSV)
2d ago

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success.

Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.

Our vision :

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission :

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

Job Description Summary

We are currently looking for an experienced Senior Validation Specialist - Computer Systems Validation (CSV) to join our Centre of Excellence for biopharmaceutical process development and small-

scale GMP manufacturing in Slough, UK.

Role Purpose and Duties :

As a Senior Validation Specialist you will be responsible for the generation and execution of validation strategy, protocols and reports in line with cGMP, industry best practice and Lonza policy across 1 of the 3 following areas :

  • Computer Systems Validation (CSV)
  • The subject matter expert (SME) for your designated area of expertise, you’ll enjoy significant autonomy in setting the Validation agenda for this area, working as part of the Validation and wider team supporting GMP manufacturing and associated functions.

    Key responsibilities :

  • Generating and executing validation project plans, protocols and reports.
  • Planning and managing delivery of validation projects and procedures to meet current GMP regulations and guidelines, industry best practice and company policy.
  • Formally reviewing validation protocols, reports and procedures generated by Lonza staff or external vendors.
  • Processing and managing quality records including change controls, deviations,and CAPAs.
  • Planing all work with and reporting progress to the validation scheduler, line manager and internal customers to ensure validation activities are aligned with QA, Quality Control, Manufacturing, Analytical Services, Manufacturing Science and Technology, Product Development and Engineering groups
  • Interested?

    What we need you to have :

  • Degree (or equivalent) in a science or (related engineering) discipline
  • Extensive experience in a Validation role within the biopharmaceuticals industry.
  • Demonstrable specific expertise in Computer Systems Validation (CSV)
  • Experience working within in a team with a commitment to supporting other colleagues .
  • Experience working in GMP environment including clean rooms and facilities.
  • Experience in managing quality records within the biopharmaceuticals industry.
  • Essential attributes :

  • Good understanding of validation principles and practices and the risk based approach
  • Good appreciation of GMP in biopharmaceuticals
  • Experience with pharmaceutical Quality Systems including change control, deviation, CAPAs.
  • Desirable :

  • Knowledge and understanding of manufacturing operations; fermentation, purification and controlled storage
  • Skills :

  • Good communicator, able to articulate complex information concisely and with sensitivity to the audience at hand and to build effective relationships with internal customers and supporting functions such as QC, QA, Engineering and Operations.
  • Able to prioritise own activities to ensure critical deadlines met
  • Who you are :

    A proactive person, you'll be able to recognise potential problems and successfully manage solutions. You'll possess an agile mind and be able to change priorities and adapt your outputs to changing business need.

    You'll be comfortable with responsibility, holding yourself - and others - accountable for actions you take and results you deliver.

    What we offer :

    We offer an excellent work environment where you can develop your skills and knowledge, the opportunity to work in a team of highly collaborative experts in a fun and dynamic atmosphere, and competitive salary and benefits.

    At Lonza we invest in great people. We encourage our employees to challenge themselves, and we offer an environment that fosters creativity and success.

    With headquarters in Basel, Switzerland, we operate production, R&D and business sites around the world, including Europe, North America and Asia.

    Notice to agencies :

    We're not looking for support with this recruitment and are unable to accept speculative details. Thank you.

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