Expert Pharmaceutical Cleanroom Operations & Technology (m/w/d)*

SCHOTT; Mainz; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading global pharmaceutical company in Mainz, Germany is seeking an Expert Pharmaceutical Cleanroom Operations & Technology. This role involves leading cleanroom operations to ensure compliance and improve processes across sites. Candidates should have a degree in a related field and at least 5 years of experience in cleanroom management within the pharmaceutical industry. Benefits include flexible working hours and a focus on employee development.

Leistungen

Flexible working hours

Holistic corporate health management

Talent development

Trust-based working time

Corporate pension plans

Qualifikationen

• At least 5 years of experience in cleanroom setup, management or operation.
• Knowledge of relevant ISO and GMP standards for cleanrooms.
• Experience working in a regulated environment.

Aufgaben

• Act as Global Process Owner for cleanroom quality processes.
• Lead global teams to ensure compliance with ISO and GMP guidelines.
• Develop and provide training on cleanroom practices.
• Monitor cleanroom standards and qualify facilities.

Kenntnisse

Cleanroom management

Contamination control

Regulatory compliance

Cross-functional teamwork

Fluent English

Ausbildung

Bachelor’s or Master’s degree in pharmaceutical or biotechnology engineering, microbiology, or related field

Jobbeschreibung

About us

Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. Every day, a team of around 4,700 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 17 manufacturing sites in Europe, North and South America, and Asia. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is majority owned by SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment.

We are looking for a dedicated Expert Pharmaceutical Cleanroom Operations & Technology (m/w/d)*to lead global cleanroom operations and processes across our sterile and non-sterile sites. This role is critical to ensuring regulatory compliance, contamination control, and continuous improvement in our cleanroom environments.

Your Contribution

• Act as Global Process Owner for the Quality processes related to definition, implementation, operation and maintenance of cleanrooms at SCHOTT Pharma
• Provide global guidance for the technical and procedural implementation of a robust contamination control strategy
• Lead global, cross-functional teams to define the standards for cleanroom design, maintenance, and continuous improvement in compliance with applicable ISO and GMP (e.g. EU GMP Guide, Annex I) guidelines
• Develop and provide regular training on cleanroom practices and foster a culture of responsibility and continuous improvement
• Support the rollout and implementation of cleanroom standards by
  • Providing methods and templates for gap assessments of processes and requirements to ensure implementation of a contamination control strategy (CCS)
  • Defining and enforcing gowning requirements and protocols for sterile and non-sterile environments
  • Developing and implementation of global monitoring programs to analyze cleanroom monitoring data and review effectiveness of corrective actions
  • Supporting and aligned qualification/validation of cleanroom facilities, utilities and equipment, including documentation
• Support of local root cause analysis and improvements in case of issues, deviations or complaints
• Track and assess new/changed regulatory requirements and industry trends to ensure timely implementation and improvements

Your Profile

• Bachelor’s or Master’s degree in pharmaceutical or biotechnology engineering, microbiology, or a related field
• At least 5 years of experience in cleanroom setup, management or operation and/or environmental monitoring/microbiology in the pharmaceutical industry
• Knowledge of relevant ISO and GMP standards for cleanrooms
• Experience working in a regulated environment, including design and implementation of GMP-compliant processes and procedures
• Good communication skills
• Fluent in English; German would be beneficial
• Project management skills and/or work experience in cross-functional teams would be an add-on

Your Benefits

SCHOTT’s openness to promote your further development is just as great as our additional benefits. Ranging from active health management via flexible working hours and hybrid work all the way to corporate pension plans: everything geared to suit your goals and needs. Discover a special corporate culture where everyone has the opportunity to develop their entire potential.

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

Flexible working hours; Holistic corporate health management; Talent development; Trust-based working time

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 AG & Co. KGaA, Human Resources, Heike Haertling,

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