Our client is currently seeking a
Compliance & Calibration Specialist
in the area of Plant Support & Compliance to support their pharmaceutical technical development organization. This organization focuses on bringing innovative therapies from clinical development to market, ensuring patients gain timely access to cutting-edge treatments.
With a strong emphasis on quality, safety, and efficiency, our client develops pharmaceutical products using advanced technologies across manufacturing, formulation, packaging, and analytical development. The Plant Support & Compliance team plays a key role in maintaining calibration and infrastructure within drug product manufacturing (solid and liquid dosage forms), ensuring smooth operations and full compliance with cGMP standards for clinical trial production.
Responsibilities
Create and manage
change controls, deviations, and CAPAs (Corrective & Preventive Actions)
Draft, review, and update
standard operating procedures (SOPs)
within the area of responsibility
Develop and maintain
calibration concepts and strategies
Perform
commissioning and decommissioning
of measuring instruments and balances
Support
equipment start-up and qualification activities
for new systems
Execute
calibration activities
for manufacturing equipment, clean utilities, analytical instruments, and environmental monitoring sensors, including GMP-compliant documentation
Coordinate and organize
calibration activities
with internal stakeholders and external service providers
Manage
instrument lifecycle
(including onboarding, certification, and decommissioning)
Maintain and update
calibration master data
in SAP / SAP S4/HANA systems
Must-Haves
Completed vocational training or degree in a
technical or pharmaceutical field
(e.g., chemical/pharma technician, automation, electrical, mechatronics, or a Life Sciences/Engineering degree such as pharmacy, biotechnology, or process engineering)
Minimum 5 years of experience in a GMP-regulated environment
(production and/or development)
Strong experience working in accordance with
cGMP guidelines
Proven experience handling
change controls, deviations, and CAPAs
Solid
technical background
with a good understanding of pharmaceutical manufacturing equipment and automation systems
Fluency in German (written and spoken)
and good English skills
Independent, proactive, and reliable working style with strong interpersonal skills and team orientation
High level of motivation, curiosity, and commitment to continuous learning
Results-driven and accountable mindset, with a focus on continuous improvement and data-based decision making
#J-18808-Ljbffr
Compliance & Calibration Specialist
in the area of Plant Support & Compliance to support their pharmaceutical technical development organization. This organization focuses on bringing innovative therapies from clinical development to market, ensuring patients gain timely access to cutting-edge treatments.
With a strong emphasis on quality, safety, and efficiency, our client develops pharmaceutical products using advanced technologies across manufacturing, formulation, packaging, and analytical development. The Plant Support & Compliance team plays a key role in maintaining calibration and infrastructure within drug product manufacturing (solid and liquid dosage forms), ensuring smooth operations and full compliance with cGMP standards for clinical trial production.
Responsibilities
Create and manage
change controls, deviations, and CAPAs (Corrective & Preventive Actions)
Draft, review, and update
standard operating procedures (SOPs)
within the area of responsibility
Develop and maintain
calibration concepts and strategies
Perform
commissioning and decommissioning
of measuring instruments and balances
Support
equipment start-up and qualification activities
for new systems
Execute
calibration activities
for manufacturing equipment, clean utilities, analytical instruments, and environmental monitoring sensors, including GMP-compliant documentation
Coordinate and organize
calibration activities
with internal stakeholders and external service providers
Manage
instrument lifecycle
(including onboarding, certification, and decommissioning)
Maintain and update
calibration master data
in SAP / SAP S4/HANA systems
Must-Haves
Completed vocational training or degree in a
technical or pharmaceutical field
(e.g., chemical/pharma technician, automation, electrical, mechatronics, or a Life Sciences/Engineering degree such as pharmacy, biotechnology, or process engineering)
Minimum 5 years of experience in a GMP-regulated environment
(production and/or development)
Strong experience working in accordance with
cGMP guidelines
Proven experience handling
change controls, deviations, and CAPAs
Solid
technical background
with a good understanding of pharmaceutical manufacturing equipment and automation systems
Fluency in German (written and spoken)
and good English skills
Independent, proactive, and reliable working style with strong interpersonal skills and team orientation
High level of motivation, curiosity, and commitment to continuous learning
Results-driven and accountable mindset, with a focus on continuous improvement and data-based decision making
#J-18808-Ljbffr
Compliance & Calibration Specialist Arbeitgeber: Actalent
Unser Unternehmen bietet eine herausragende Arbeitsumgebung für Medical Science Liaisons, die sich leidenschaftlich für die Dermatologie und Autoimmunerkrankungen einsetzen. Mit einem starken Fokus auf wissenschaftlichen Austausch und strategischer Partnerschaft fördern wir eine Kultur der Zusammenarbeit und des kontinuierlichen Lernens, die es unseren Mitarbeitern ermöglicht, in ihrer Karriere zu wachsen und bedeutende Beiträge zur medizinischen Gemeinschaft zu leisten. Darüber hinaus profitieren unsere Mitarbeiter von flexiblen Arbeitsmodellen und einer unterstützenden Teamatmosphäre, die Innovation und Engagement schätzt.
