OE & Metrology Associate Analyst

WuXi Biologics; Wuppertal; Vor Ort; EUR 42.000 - 62.000; Vollzeit

Zusammenfassung

WuXi Biologics in Germany seeks an E-System and QC instrument administrator to support electronic system administration, instrument lifecycle management and metrology. You will contribute to GMP-aligned documentation, training, and procurement workflows while ensuring calibration and maintenance are performed on schedule.

The role requires microbiology background, GMP knowledge, and fluency in English and German, with strong communication and problem-solving skills in a lab environment.

Qualifikationen

• Graduation as technical assistant or higher in microbiology/biochemistry/molecular biology/chemistry or equivalent.
• GMP knowledge aligned with EMA/FDA/ICH/WHO standards is required or beneficial.
• Experience with instrument management and calibration workflows.
• Experience in microbiology laboratory environments.
• Strong metrology and electronic systems knowledge.
• Familiarity with sample and reference standard management workflows.
• Good written and spoken English and German.
• Experience with training, document management and procurement workflows is advantageous.
• Experience in managing samples, reference standards, regulatory retains and stability samples.

Aufgaben

• Support electronic system administration of the OE team.
• Support electronic system management (LIMS and Empower).
• Manage instrument life cycle; calibrations and maintenance.
• Lab administration for QC instruments and E-System.
• Write and revise QC department documents (SOPs, AMPs, protocols, reports).
• Support QC operations including samples, regulatory retains, training, document management and procurement.
• Test samples (water, production) and document results; note testing restrictions in certain roles.
• Manage metrology activities and ensure calibration/maintenance completion on time.
• Troubleshoot instruments and electronic systems as required.
• Review SOPs/protocols/reports related to Metrology/OE.

Kenntnisse

Instrument management

Microbiology

Metrology knowledge

GMP knowledge

Documentation & training

Communication (ENG/DEU)

Procurement workflow

Sample management

E-System administration

Ausbildung

Technical/Science degree (TA/Bachelor/Master) in microbiology/biochemistry/molecular biology/chemistry

Tools

Empower

LIMS

QC instruments

Jobbeschreibung

• Supporting electronic system administration of OE team
• Supporting electronic system administration (LIMS and Empower)
• Instrument life cycle management including but not limited to setting up new instrument and electronic system management, performing calibrations and maintenance.
• Lab admin for QC instruments and E-System
• Writing and revising documents for the QC department including, but not limited to, SOPs, AMPs, protocols, reports, and other technical documents
• Supporting QC operations, including but not limited to samples, reference standard regulatory retains and stability samples management, training management, document management and procurement, QC budget management and proposal management within Germany QC at WuXi Biologics.
• Testing samples including, but not limited to, water samples and production samples (bioburden, endotoxins, conductivity, TOC, etc.), and performing the related documentation of the tests and the results*

*Testing is prohibited when the employee is assigned as laboratory/instrument administrator

• Graduation as technical assistant, Bachelor degree, Master degree or comparable degree in microbiology, biochemistry, molecular biology, chemistry or another comparable field
• Knowledge in GMP requirements of EMA, FDA and other relevant standards, e.g. ICH or WHO
• Experience with Instrument management
• Experience in microbiology
• Strong technical knowledge of Metrology and electronic system
• Familiar with sample and reference standard management workflow
• Good communication skills in Englisch and German (written and spoken)
• Familiar with training, document management and procurement workflow would be beneficial
• Sample management, including receiving, inventory, storage, distribution and disposition of samples, reference standard, regulatory retains, stability samples, etc.
• Responsible for managing QC relevant proposals, including providing QC prices, updating QC prices and so on
• Supporting QC procurement, including purchase, receiving, and invoice conformation
• Manage inventory of reagents and consumables
• Manage and track the schedule of metrology activities and ensure that the calibration and maintenance is carried out on time
• Lab administrator for E-System like: Empower, LIMS and QC instruments
• Troubleshoot the instruments and electronic system as required
• Review SOP/ protocol/ report related to Metrology/ OE
• Responsible for quality events related to OE, Metrology and electronic systems such as deviation, OOS, CC