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Validation Engineer

vor 1 Woche

St Gallen, Sankt Gallen, Schweiz SCHOTT Pharma Schweiz AG Vollzeit
About us

SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world - because human health matters. The portfolio comprises drug containment and delivery solutions for injectable drugs ranging from prefillable glass and polymer syringes, to cartridges, vials, and ampoules. Every day, a team of around 4,700 people from over 65 nations works at SCHOTT Pharma to contribute to global healthcare.

Become our (Senior) Validation Engineer* within our R&D and Global Engineering division at SCHOTT Pharma. This position will be located at our site in St. Gallen, Switzerland. Travelling to global production sites will be project-specific and around 10%.

Your Responsibilities

  • You develop the qualification and validation strategy for local and global (=international) projects and consult the whole organization on the subject of qualification and validation

  • You are accountable for planning and execution of qualification & validation activities (including project management and coordination) within global development and CAPEX-projects worldwide.

  • You perform and moderate risk analysis (e.g. GMP-RA, FMEA) according to specifications and standards

  • You create, review and update qualification & validation documents (e.g. plan, test plan, protocol, report)

  • You actively shape the continuous development of qualification and validation and thereby support the growth of SCHOTT Pharma

Your Qualifications

  • University degree in engineering, computer science, life sciences or comparable education including advanced training

  • Practical work experience (> 3 years) in qualification and/or validation in a regulated environment (pharmaceutical industry desirable) with appropriate mindset

  • Solid knowledge of GMP (Good Manufacturing Practice), data integrity, GAMP, 21 CFR Part 11, EU-GMP Annex 11, and good documentation practice

  • Good technical understanding and analytical skills; experience in technical writing is a plus

  • Intercultural openness, good communication skills and an entrepreneurial and structured way of working

Your Benefits

At SCHOTT, you can expect a unique corporate culture where we emphasize equity, diversity and inclusion. We know: motivated and committed employees are the condition for the success of our company.

Please feel free to contact us

You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future. Do you want to be successful with us? Then, please send us your application: SCHOTT Pharma Schweiz AG, Human Resources, Kristina Ettemeyer+41712740849

*At SCHOTT, it's your personality that counts - not your gender, your identity, or origin.

SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for

people around the world - because human health matters. The portfolio comprises drug containment and delivery solutions for injectable drugs ranging from prefillable glass and polymer syringes, to cartridges, vials, and ampoules. Every day, a team of around 4,700 people from over 65 nations works at SCHOTT Pharma to contribute to global healthcare.

Become our (Senior) Validation Engineer* within our R&D and Global Engineering division at SCHOTT Pharma. This position will be located at our site in St. Gallen, Switzerland. Travelling to global production sites will be project-specific and around 10%.

Your Responsibilities

  • You develop the qualification and validation strategy for local and global (=international) projects and consult the whole organization on the subject of qualification and validation

  • You are accountable for planning and execution of qualification & validation activities (including project management and coordination) within global development and CAPEX-projects worldwide.

  • You perform and moderate risk analysis (e.g. GMP-RA, FMEA) according to specifications and standards

  • You create, review and update qualification & validation documents (e.g. plan, test plan, protocol, report)

  • You actively shape the continuous development of qualification and validation and thereby support the growth of SCHOTT Pharma

Your Qualifications

  • University degree in engineering, computer science, life sciences or comparable education including advanced training

  • Practical work experience (> 3 years) in qualification and/or validation in a regulated environment (pharmaceutical industry desirable) with appropriate mindset

  • Solid knowledge of GMP (Good Manufacturing Practice), data integrity, GAMP