Senior Technical Manager for Validation and Calibration

Senior Technical Manager for Validation and Calibration

Speke, Liverpool

Competitive Salary and benefits

Build a long-term career by unlocking opportunities for lifelong learning.

Build unrivalled capabilities in a place that promotes learning agility and offers development opportunities. We never stand still so you’ll have the chance to constantly grow your abilities, skills and knowledge. Here we are a fusion of challenging and interesting work, in an energising and inspiring environment.

Do you feel passionate about the possibilities of applying science to changing lives? Do you have experience working within biopharmaceutical process development? If so, this may be the role for you!

The role is located at AstraZeneca’s manufacturing site a short distance from the exciting city centre of Liverpool. Rich in history, as well being a creative hub, Liverpool offers an attractive cost of living along with a great quality of life. The city has something for everyone; live music, an exciting food and restaurant scene, nationally famous art galleries, excellent shopping and world-class museums.

We are looking for a Senior Technical Manager for Validation and Calibration to join us on a permanent basis as part of the Engineering & Facilities Team.

What you’ll do

As a role model we’ll expect you to Champion Safety as our number one priority aligned to AstraZeneca Values and behaviours.

You’ll develop and implement the site’s validation/calibration strategy to ensure continued compliance with regulatory requirements (cGMP, GAMP, ICH, ISPE); Corporate and site procedures and Good Engineering Practice, providing a high level of customer service as measured via TIER process

We’ll expect you to proactively lead and develop the performance of your team and relevant external service providers to ensure alignment to schedule, efficient delivery of operations and process optimisation.

You’ll lead resource capacity modelling to assure delivery of compliant operations within team and both site & global project portfolio.

By effective handling of assigned Quality Records and Key Quality Documents you’ll ensure timely and effective completion.

Through proactive collaboration across all functions, you’ll ensure the effective and timely delivery of QMS and change activities.

Proactively support the sites Change Management Process and the Change Review Board as technical expert.

We’ll ask you to collaborate with the wider AstraZeneca network ensuring continued development and optimisation of the Validation /Calibration Management system aligned to AstraZeneca strategy.

As Business Process Owner for Validation and Calibration activities – proactively utilise Lean to drive continuous improvement across process and procedures with the aim of reducing waste and increasing benefits.

You’ll recognise where there are gaps between business needs and known and emerging technologies and participate in the development of strategies to close technology gaps.

You’ll drive education and development of team and site on the business processes within your expertise.

Required criteria

  • Engineering or Science degree or equivalent in Control and Instrumentation Engineering or Biochemistry, Chemistry, Microbiology, Virology, Biochemical Engineering.
  • Previous experience leading a multi-disciplined team.
  • Strong organisational skills and management – coaching and mentoring experience
  • Extensive knowledge of cGMP standards, in particular manufacturing, laboratory and requirements for computer systems (GAMP) and data integrity
  • Understanding of GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines
  • The role holder will have considerable technical knowledge and subject matter expertise.

This is a phenomenal opportunity in a very hardworking team, who will bring the best out of standout colleagues, and those with a dream to succeed.

If you are interested in this opportunity, apply today!

This role is open from 05/05/2021 and we welcome your application no later than 23/05/2021

Where can I find out more?

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